← Product Code [DXN](/productcode/DXN) · K261082 # Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) (K261082) _Microlife Corporation · DXN · Jul 23, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K261082 ## Device Facts - **Applicant:** Microlife Corporation - **Product Code:** [DXN](/productcode/DXN.md) - **Decision Date:** Jul 23, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Microlife Wrist Blood Pressure Monitor Model, BPHJG5-G is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. ## Device Story Wrist-worn oscillometric blood pressure monitor; measures systolic/diastolic pressure and pulse rate. Input: cuff pressure oscillations detected by semiconductor sensor during inflation. Processing: microprocessor (HY16F198B) converts pressure changes to electrical signals; applies oscillometric algorithm (yi6) to calculate BP and pulse. Output: digital LCD display of BP, pulse, and irregular heartbeat warning. Used in home/clinical settings by patients or clinicians. Powered by AAA batteries or AC/DC adapter. Benefits: enables self-monitoring of blood pressure and detection of irregular heartbeats. ## Clinical Evidence Clinical validation study conducted per ISO 81060-2:2018 (including AMD 1:2020 & AMD 2:2024) on 85 subjects (mean age 63.4 years). Mean difference ± SD between test device and reference was 1.23 ± 7.2 mmHg (systolic) and -0.27 ± 6.22 mmHg (diastolic). SD of average BP differences per individual was 6.09/5.13 mmHg (systolic/diastolic). Results demonstrate compliance with validation criteria. ## Technological Characteristics Oscillometric measurement; semiconductor pressure sensor; HY16F198B MCU (8 MHz). Powered by 2x AAA batteries or 5V/1A AC/DC adapter. Nylon cuff (13.5-21.5cm). Digital LCD. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 10993-1/5/10, AAMI/ANSI/IEC 80601-2-30, IEC 60601-1-11. ## Regulatory Identification A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body. ## Predicate Devices - Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B ([K211288](/device/K211288.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} ![LOGO](U.S. Food & Drug Administration) July 23, 2026 Microlife Corporation % Vaibhav Arvind Rajal Senior Regulatory Affairs Consultant Mdi Consultants, Inc. Contact Address Re: K261082 Trade/Device Name: Microlife Wrist Blood Pressure Monitor (Model BPHJG5-G) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 30, 2026 Received: June 30, 2026 Dear Vaibhav Arvind Rajal: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261082 - Vaibhav Arvind Rajal Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K261082 - Vaibhav Arvind Rajal Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, STEPHEN C. BROWNING -S CDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K261082 Device Name Microlife Wrist Blood Pressure Monitor (Model BPHJG5-G) Indications for Use (Describe) The Microlife Wrist Blood Pressure Monitor Model, BPHJG5-G is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} # 510(k) SUMMARY The assigned 510(k) number is: K261082. # 1. Submitter's Identification: Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei 11492, Taiwan, China Date Summary Prepared: July 10, 2026 Contact: Mr. Jimmy Deng Global Regulatory Affairs & Quality Management Director Microlife Corporation Tel: 886-2-87971288 # 376 Email: Jimmy.Deng@microlife.com.tw # 2. Name of the Device: Microlife Wrist Blood Pressure Monitor (Model BPHJG5-G) Regulation Number: 21 CFR Part 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II Product Code: DXN # 3. Information for the 510(k) Cleared Device (Predicate Device): Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B, K211288, Microlife Intellectual Property GmbH. # 4. Device Description: Microlife Wrist Blood Pressure Monitor Model, Model BPHJG5-G is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". # 5. Indications for Use: The Microlife Wrist Blood Pressure Monitor Model, BPHJG5-G is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. Page 1 of 8 K261082 {5} The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. # 6. Comparison to the 510(k) Cleared Device (Predicate Device): | Item | 1. Predicate device (Primary): Microlife Wrist Watch BPM BP3GK1-4B, Microlife Intellectual Property GmbH, K211288 | Subject device: Microlife Wrist Blood Pressure Monitor BPHJG5-G, Microlife Intellectual Property GmbH | Similar or Different | | --- | --- | --- | --- | | Indications for Use | The Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. The device can be used in connection with a smartphone running the APP. The memory data can be transferred to the smartphone via Bluetooth. | The Microlife Wrist Blood Pressure Monitor Model, BPHJG5-G is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. | Different | | Device Technology | Oscillometric method | Oscillometric method | ✓ | | Measuring Location | Wrist | Wrist | ✓ | | Appearance (ID design) | | | Different | | Physical Dimension | 81 x 65 x 21 mm 3.19 x 2.56 x 0.83 inch | 89 x 74 x 22 mm 3.50 x 2.91 x 0.87 inch | Different | | Microprocessor | HY16F198B 1. HYCOM MCU core 2. Main clock frequency: 8 MHz 3. Sub clock frequency: 32.768 kHz 4. System voltage level: 3.3V 5. Pressure sensor type: Semiconductor sensor 6. The amount of MCU pins: 100 pins | HY16F198B 1. HYCOM MCU core 2. Main clock frequency: 8 MHz 3. Sub clock frequency: 32.768 kHz 4. System voltage level: 3.3V 5. Pressure sensor type: Semiconductor sensor 6. The amount of MCU pins: 100 pins | ✓ | Page 2 of 8 K261082 {6} | Item | 1. Predicate device (Primary): Microlife Wrist Watch BPM BP3GK1-4B, Microlife Intellectual Property GmbH, K211288 | Subject device: Microlife Wrist Blood Pressure Monitor BPHJG5-G, Microlife Intellectual Property GmbH | Similar or Different | | --- | --- | --- | --- | | Sensor | Semiconductorsensor | Semiconductorsensor | ✓ | | F/W reversion of Algorithm | Yi2 1. Blood pressure algorithm: Wrist for inflation measurement 2. Signal filter: FIR filter 3. Algorithm: Oscillometric measurement 4. Irregular heart beat detection: IHD | Yi6 1. Blood pressure algorithm: Wrist for inflation measurement 2. Signal filter: FIR filter 3. Algorithm: Oscillometric measurement 4. Irregular heart beat detection: IHD | Different | | Signal Detection Technology | Detect electrical while inflating (Called "IMT" technology) | Detect electrical while inflating (Called "IMT" technology) | ✓ | | Display | Digital liquid crystal display | Digital liquid crystal display | Different | | Pressure and Pulse Rate Accuracy | Pressure within ±3 mmHg or 2% of reading >200mmHg Pulse ±5% of the reading | Pressure within ±3 mmHg Pulse ±5% of the reading | ✓ | | Measuring Range | SYS: 60-255 mmHg DIA: 40-200 mmHg Pulse: 40 to 199 per minute | SYS: 60-255 mmHg DIA: 40-200 mmHg Pulse: 40 to 199 per minute | ✓ | | Pressure Resolution | 1mmHg | 1mmHg | ✓ | | Cuff Display Range | 0 to 299mmHg | 0 to 299mmHg | ✓ | | Power Source | 2 Batteries, Size AAA 1.5V | 2 Batteries, Size AAA 1.5V, Or AC adapter DC 5V, 1.0 A | Different | | Low Battery Voltage Detection | Yes | Yes | ✓ | | User | 2 | 2 | ✓ | | Last Measurement Recall | 2*100 sets | 2*99 sets | Different | | Beeper Indication | Yes | NO | Different | | Irregular Heartbeat Detection Function | Yes | Yes | ✓ | | Traffic Light Function | Yes | Yes | ✓ | | MAM function | Yes | Yes | ✓ | Page 3 of 8 K261082 {7} | Item | 1. Predicate device (Primary): Microlife Wrist Watch BPM BP3GK1-4B, Microlife Intellectual Property GmbH, K211288 | Subject device: Microlife Wrist Blood Pressure Monitor BPHJG5-G, Microlife Intellectual Property GmbH | Similar or Different | | --- | --- | --- | --- | | Wrist Position Check function | Yes | Yes | ✓ | | Cuff fit check function | Yes | Yes | ✓ | | MyCheck function | Yes | Yes | ✓ | | MyBP function | Yes | NO | Different | | AC/DC Adaptor Compatible | NO | Yes | Different | | AM/PM Average stored Function | Yes | No | Different | | 28-Day Memory Average | No | Yes | Different | | Bluetooth function | Yes Using Bluetooth(4.2) | NO | Different | | Operation Range | +10°C to +40°C at RH 15% to 90% | +10°C to +40°C at RH 15% to 90% | ✓ | | Storage Range | -20°C to +55°C at RH 15% to 90% | -20°C to +55°C at RH 15% to 90% | ✓ | | Life Time | At least 10000 times of operation | At least 10000 times of operation | ✓ | | Cuff material | Flannelette cuff cloth PVC bladder | Nylon cuff cloth PVC bladder | Different | | Quick exhaust valve | Electromechanical solenoid valve | Electromechanical solenoid valve | ✓ | | Accessories | **Necessary:** Cuff for wrist circumference 13.5-21.5cm AAA batteries Instruction manual Gift box | **Necessary:** Cuff for wrist circumference 13.5-21.5cm AAA batteries Instruction manual Gift box Storage case **Special(optional):** Adapter(out 5V 1A5W) | Different | Based on information from the comparison chart: The differences and changes are power source, and the non-clinical functions will be discussed as below. The measurement algorithm and mechanism of operation, as well as the safety & essential performance of the devices remain identical before and after the changes. The subject (Modified) device BPHJG5-G uses the same oscillometric method as the predicate device BP3GK1-4B with the same fundamental scientific technology to determine the systolic and diastolic blood pressure and pulse rate. Cuff is inflated Page 4 of 8 K261082 {8} automatically by pump and the pressures are transferred via tubing to a sensor in these units. The subject (Modified) device BPHJG5-G and the predicate device BP3GK1-4B have traffic light function, MAM function, IHD function, IMT technology, Cuff fit check function, 2 users function and MyCheck function. The differences between these devices are: # 1) Indications for Use The subject device BPHJG5-G and predicate device BP3GK1-4B both are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The differences between subject device and predicate device both are the Bluetooth function. The predicate device BP3GK1-4B can be used in connection with a smart phone running the APP and the memory data can be transferred to the smart phone via Bluetooth. However, this function is only a way to transfer the data and does not affect effectiveness and safety. # 2) Physical Dimension The physical dimension of the subject device BPHJG5-G is 89 x 74 x 22 mm, while predicate device BP3GK1-4B is 81 x 65 x 21 mm. The difference is caused because of their Different appearance, but the difference does not raise any new safety and effectiveness questions. This has been tested and confirmed according to IEC 60601-1-2 EMC Test Report, IEC 60601-1, AAMIANSI ES60601-1 Safety Test Report and IEC 80601-2-30 Test Report. # 3) Display The subject device BPHJG5-G and predicate device BP3GK1-4B both have digital liquid crystal display. The only difference is the UI. But, it does not affect the effectiveness according to the essential performance testing. # 4) F/W reversion of Algorithm The algorithm of subject device BPHJG5-G is yi6, while predicate device BP3GK1-4B is yi2. The only difference is the algorithm version, because the BPHJG5-G incorporates an additional adapter-based power supply function. However, their calculation algorithm is the same. It does not affect performance and accuracy which was evaluated in the performance testing. # 5) Last Measurement Recall The subject device BPHJG5-G and predicate device BP3GK1-4B have Different number of stored measurement values. This does not affect effectiveness and safety. # 6) My BP function The subject device BPHJG5-G does not have the MyBP function, whereas the predicate device BP3GK1-4B have the function. The MyBP function provides the user with an averaged blood pressure value, which includes only readings taken in the morning or evening of the most recent 3 to 7 days for computation, per clinical guideline suggestions (of taking multiple readings in the morning and evening). The MyBP average value is displayed only when sufficient number of readings meeting the criteria have been obtained, to provide a more clinically relevant average. If Page 5 of 8 K261082 {9} data in the memory are insufficient, it is not displayed. This function is based on the measured data, so this doesn't affect the device essential performance. # 7) AM/PM Average Stored Function The subject device BPHJG5-G does not have the AM/PM average stored function, whereas the predicate device BP3GK1-4B has the function. The AM/PM average stored function is to give an average result based on AM or PM measurements are taken. This function is based on the measured data, so this doesn't affect the clinical test. # 8) 28-Day Memory Average The subject device BPHJG5-G has the 28-Day Memory Average function, whereas the predicate device BP3GK1-4B does not have the function. The AM/PM average stored function refers to calculating the average of all measured values within a 28-day period. This function is based on the measured data, so this doesn't affect the clinical test. # 9) Bluetooth function The subject device BPHJG5-G does not have the Bluetooth function, whereas the predicate device BP3GK1-4B has the function. This function is only a way to transfer the data and is based on the measured data, so it does not affect effectiveness and safety according to the performance testing and safety testing. # 10) Beeper Indication The subject device BPHJG5-G does not have the Beeper Indication, whereas the predicate device BP3GK1-4B has the function. This function provides audio alerts during operation. For example, a beep will sound at the start and end of a measurement to notify the user. Therefore, it does not affect effectiveness and safety according to the performance testing and safety testing. # 11) Power Source The power supply of the subject device BPHJG5-G is compatible with not only AAA batteries but also AC/DC Adaptor whereas the predicate device BP3GK1-4B is only compatible with AAA batteries. But the difference does not raise any new safety and effectiveness questions. This does not affect the device essential performance. This has been tested and confirmed according to IEC 60601-1-2 EMC Test Report, IEC 60601-1, AAMIANSI ES60601-1 Safety Test Report and IEC 80601-2-30 Test Report. # 12) Cuff material The subject device BPHJG5-G uses nylon cloth for cuff material, whereas the predicate device BP3GK1-4B uses flannelette cloth. As the bladder is the same, the Different cloth material does not affect effectiveness and safety. A biological evaluation was conducted for the blood pressure cuff in compliance with ISO 10993-1 Based upon the aforementioned information, the two devices are substantially equivalent. # 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Page 6 of 8 K261082 {10} Testing information demonstrating the safety and effectiveness of the Microlife Wrist Blood Pressure Monitor Model, Model BPHJG5-G in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft “Reviewer Guidance for Premarket Notification Submissions”, DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements. The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate device: The following National and International Standards were utilized for testing the subject device: 1) ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 &A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2(2021)] 2) IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests 3) ISO 14971: 2019 Medical devices – Application of risk management of medical devices. 4) ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 5) ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity 6) AAMI/ANSI/IEC 80601-2-30:2018 Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers 7) ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization 8) IEC 60601-1-11:2020 Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Microlife Wrist Blood Pressure Monitor Model, Model BPHJG5-G tested met all relevant requirements of the aforementioned tests. # 8. Discussion of Clinical Tests Performed: The Microlife W2 Slim automated blood pressure monitors fulfilled the ISO 81060- Page 7 of 8 K261082 {11} 2:2018 (including AMD 1:2020 & AMD 2:2024) protocols, and can be recommended for self-measurement in the general population. The study were tested on 85 were analyzed [mean age: 63.4 ± 18.0 (SD) years, 34 men, 51 women, wrist circumference 17.5 ± 2.2 cm, range: 13.5–21.5 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings (N = 255) was 1.23 ± 7.2/−0.27 ± 6.22 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For criterion 2, the SD of the average BP differences between the test device and reference BP per individual (N = 85) was 6.09/5.13 mmHg (systolic/diastolic; threshold ≤ 6.84/6.95 mmHg). Based on Declaration of Identity, the Microlife wrist blood pressure monitor BPHJG5-G is from the technical point of view identical to the Microlife wrist blood pressure monitor W2 Slim (model number BP3GK1-4E). The clinical validation results of W2 Slim are applicable to BPHJG5-G. The study participants were recruited from two clinical sites: the Department of Outpatients and Cardiology at the Second Hospital of Xi'an City / Xijing Hospital (Xi'an, China), and the Department of Cardiology at Taipei Veterans General Hospital (Taipei, Taiwan). All participants provided written informed consent prior to enrolment. #### **9. Software information:** Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". #### **10. Conclusions:** Conclusions drawn from the non-clinical and clinical tests demonstrate that the subject device is as safe, effective, and performs as well as the predicate device. Page 8 of 8 K261082 --- **Source:** [https://fda-staging.innolitics.com/device/K261082](https://fda-staging.innolitics.com/device/K261082) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com