Upper Arm Blood pressure monitor (BP7155D)

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 10, 2026 OMRON Healthcare, Inc. Bhoomika Joyappa Regulatory Specialist 2895 Greenspoint Pkwy. Suite 100 Hoffman Estates, Illinois 60169 Re: K261929 Trade/Device Name: Upper Arm Blood pressure monitor (BP7155D) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 12, 2026 Received: August 12, 2026 Dear Bhoomika Joyappa: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261929 - Bhoomika Joyappa Page 2 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" (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. 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 {2} K261929 - Bhoomika Joyappa Page 3 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} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261929 | ? | | Please provide the device trade name(s). | | ? | | Upper Arm Blood pressure monitor (BP7155D) | | | | Please provide your Indications for Use below. | | ? | | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. | | | | Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | Page 1 of 1 {4} # 510(k) Summary ## I. Submitter Information Omron Healthcare, Inc. Address: 2895 Greenspoint Pkwy, Hoffman Estates, IL 60169 Primary contact person: Bhoomika Joyappa Date prepared: May 22, 2026 ## II. Subject Device: Trade Name: Upper Arm Blood pressure monitor (BP7155D) 510(k): TBD, Special Classification Name: Noninvasive Blood Pressure Measurement System Regulation: 21 CFR 870.1130 Regulatory Class: II Product classification code: DXN ## III. Predicate Device Predicate Device: Omron Upper Arm Blood Pressure Monitor Model: HEM-7311 510(k): K133379 Classification Name: Noninvasive Blood Pressure Measurement System Regulation: 21 CFR 870.1130 K261929 Page 1 of 9 {5} Regulatory Class: II Product classification code: DXN # IV. Device Description The Omron BP7155D is a battery-powered, non-invasive upper arm blood pressure monitor intended for OTC home use. The device measures systolic blood pressure, diastolic blood pressure, and pulse rate using the oscillometric measurement method. The device also detects irregular heartbeats during measurement and provides a corresponding indication to the user. The BP7155D incorporates Bluetooth Low Energy (BLE) functionality to enable wireless transmission of stored blood pressure and pulse measurement data to external applications. The BLE functionality is limited to communication and transfer of previously measured and displayed data and does not affect blood pressure measurement, calculation, analysis, or displayed results. The device continues to operate independently even when BLE communication is unavailable. # V. Indications for Use The device is a digital monitor intended for use in measuring blood pressure and pulse rate in the adult patient population. The device detects the appearance of irregular heartbeats during measurement and provides a warning indication with readings. K261929 Page 2 of 9 {6} # VI. Comparison of Technological Characteristics with the Primary Predicate Device | Characteristics | Predicate Device HEM-7311 | Subject Device BP7155D | Rationale for Change from Cleared (Primary Predicate) Device | | --- | --- | --- | --- | | Regulation Number and Description | 21 CFR§870.1130, Noninvasive blood pressure measurement system. | 21 CFR§870.1130, Noninvasive blood pressure measurement system. | Identical to predicate | | Regulatory Class | II | II | Identical to predicate | | Product Code | DXN - Noninvasive blood pressure measurement | DXN - Noninvasive blood pressure measurement | Identical to predicate | | Indications for Use | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. | Identical to predicate | K261929 Page 3 of 9 {7} | Measurement body part | Upper Arm | Upper Arm | Identical to predicate | | --- | --- | --- | --- | | Environment of Use | Home Use | Home Use | Identical to predicate | | Type of Use | OTC | OTC: | Identical to predicate | | Patient Population | Adult | Adult | Identical to predicate | | Sterility | External contacting device, nonsterile | External contacting device, nonsterile | Identical to predicate | | Measurement Method / Principal of Operation | Cuff oscillometric method | Cuff oscillometric method | Identical to predicate | | Measurement Range | Pressure: 0 to 299mmHg Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299mmHg Pulse Rate: 40 to 180 beats/min. | Identical to predicate | | software-based functional features | 1. Irregular heartbeat feature 2. Body movement detection 3. Hypertension indicator | 1. Irregular heartbeat feature 2. 2. Body movement detection 3. 3. Hypertension indicator | Identical to predicate | | Pressure Sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Identical to predicate | | Applicable cuff (Arm Circumference) | 17-22cm (HEM-CS24) 22-42cm (HEM-RML31) | 17-22cm (HEM-CS24-C) 22-42cm (HEM-RML31-C) | Cuff(s) are exactly the identical to predicate devices but the cuff connector is changed for complying with the latest global standard. Although the connector design differs from the predicate, it has been evaluated in accordance with applicable global standards (IEC80369-5:2016). This difference does not impact the device's safety, performance, or effectiveness. | K261929 Page 4 of 9 {8} | Accuracy of pressure indicator | Within ±3mmHg or 2% of reading | Within ±3mmHg or 2% of reading | Identical to predicate | | --- | --- | --- | --- | | Accuracy of pulse rate | Within 5% of reading | Within 5% of reading | Identical to predicate | | Inflation Method | Automatic inflation by electric pump | Automatic inflation by electric pump | Identical to predicate | | Deflation Method | Automatic pressure release valve | Automatic pressure release valve | Identical to predicate | | Display | LCD digital display on device | LCD digital display on device | Identical to predicate | | Power Source | 4 “AA” batteries or AC adapter | 4 “AA” batteries or AC adapter | Identical to predicate | | Dimensions (mm) | 183 (w) × 99(h) × 230 (l) mm | 98 (w) × 79 (h) ×138 (l) mm | The dimensional reduction does not affect the device’s fundamental design or performance. The internal architecture, sensing algorithm, and pressure pathway remain identical to the predicate configuration, ensuring measurement equivalence. The change is limited to a minor cosmetic and ergonomic enhancement — a reduced enclosure size that improves handling and storage convenience. There are no changes to the intended use, performance, or safety of the device. | | Weight | Approximately 22 oz (640g) (not including batteries) | Approximately 9 oz (260g) (not including batteries) | The proposed device has a reduced weight compared to the predicate device. The reduction in weight does not affect the device’s ability to accurately measure blood pressure or pulse rate. Additionally, the device remains suitable for its intended use environment (home use), and the change may improve ease of handling and user comfort. | K261929 Page 5 of 9 {9} | Main Materials | Enclosure: ABS Cuff: PA | Enclosure: ABS Cuff: PA | Identical to predicate | | --- | --- | --- | --- | | Wireless communication | None | Bluetooth Low Energy | Data transmitted via BLE to external applications is identical to that displayed on the device and is not modified during transmission. The predicate device does not include wireless communication functionality. The proposed device incorporates Bluetooth Low Energy (BLE) to enable transmission of stored blood pressure and pulse data to external applications. The BLE functionality is limited to data transfer and does not affect the device's measurement, analysis, or display of results. Data transmitted via BLE is identical to that displayed on the device and is not modified during transmission. The device continues to operate independently of BLE connectivity. Appropriate controls have been implemented to ensure data integrity and reliable communication. Any loss or degradation of wireless connectivity does not impact on the device's performance, including blood pressure measurement, accuracy and display. Therefore, the addition of BLE functionality represents an interoperability enhancement and does not raise new questions of safety or effectiveness. | | Memory Capacity | 90 BP readings can be stored in internal memory. | 30 BP readings can be stored in internal memory. | Identical to predicate | | Power Supply | Regulates power voltage regardless of battery voltage. | Regulates power voltage regardless of battery voltage. | Identical to predicate | K261929 Page 6 of 9 {10} ## VII. Technological Characteristics The BP7155D has the same intended use, operating principle, patient population, measurement method, pressure sensor technology, measurement algorithm, and core blood pressure measurement functionality, applicable cuff(s), and applicable arm circumference range as the predicate device. Both devices utilize cuff oscillometric method for blood pressure determination. The primary technological difference between the proposed device and the predicate device is the addition of Bluetooth Low Energy (BLE) communication functionality. The BLE functionality only enables transmission of stored blood pressure and pulse data to external applications and does not modify or influence measurement performance, displayed results, or device operation. The BLE communication does not control, modify, interpret, analyze, or influence blood pressure measurement performance, measurement algorithms, cuff control, displayed results, or clinical interpretation of measurement data. The device continues to perform blood pressure measurements independently even when BLE functionality is not used. The data transmitted via BLE communication is identical to the measurement results displayed on the device screen. Data transmitted via BLE is identical to that displayed on the device. Additional differences include minor updates to: - Device dimensions and weight - Cuff connector design to comply with IEC 80369-5:2016 These modifications do not affect the intended use, safety, or effectiveness of the device. ## VIII. Performance Testing ### Electrical Safety and EMC Electrical safety testing conducted in accordance with IEC 60601-1 and IEC 60601-1-11 for the predicate device remains applicable, as no changes were made to the electrical design that would impact safety. The addition of BLE does not affect the device's electrical safety profile. K261929 Page 7 of 9 {11} Electromagnetic compatibility (EMC) testing was evaluated to include BLE functionality and confirmed that the device meets applicable requirements without impacting performance. EMC testing was conducted in accordance with IEC 60601-1-2 to ensure that the device operates safely and effectively in the presence of electromagnetic disturbances. The device met all applicable emissions and immunity requirements, and essential performance was maintained under all tested conditions. ## Software Verification and Validation The BP7155D utilizes the same measurement algorithms, logic, and core functionality for blood pressure measurement and analysis as the cleared predicate device (K133379). No changes have been made to the software components that impact measurement performance, including pressure sensing, calculation, or result determination functions. The software safety classification for the measurement functionality remains unchanged. The primary software modification is the addition of Bluetooth Low Energy (BLE) functionality to enable transmission of stored data to external applications. This functionality is limited to data communication and does not affect measurement, analysis, or display of blood pressure results. The external applications are intended solely for the transfer, storage, and display of the data, and are therefore considered non-device software functions not subject to the medical device regulation. Software development, verification, and validation activities were conducted in accordance with: - FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - IEC 62304: Medical device software – Software life cycle processes Verification and validation testing included evaluation of BLE connectivity, data transmission, data integrity, and system behavior under normal and fault conditions. Results demonstrate that data transmitted via BLE is identical to that displayed on the device and is not modified during transmission. Previously established software verification and validation testing for the predicate device remains applicable to the measurement functionality. Risk management activities were updated to address BLE-related considerations, including data integrity and K261929 Page 8 of 9 {12} communication reliability, in accordance with FDA cybersecurity guidance. No new risks were identified that impact safety or effectiveness. Accordingly, the software modifications do not affect the device's core performance, and the software continues to perform as intended. The device does not raise new questions of safety or effectiveness. # Biocompatibility The proposed device does not introduce new patient-contacting materials compared to the predicate device. Previously established biocompatibility testing conducted in accordance with ISO 10993-1 remains applicable to the subject device. # Clinical Validation The BP7155D utilizes the same validated monitoring technology as the predicate device, with no changes to sensors, applicable cuff(s), measurement algorithms, or blood pressure measurement accuracy. The device leverages the clinical validation previously established for the predicate device under ANSI/AAMI/IEC 81060-2. Additional clinical testing was not considered necessary because the addition of BLE functionality is limited to data transmission and does not affect measurement performance or clinical interpretation. # IX. Substantial Equivalence Conclusion The BP7155D is substantially equivalent to the predicate device (K133379) with respect to intended use, operating principle, technological characteristics, and performance. The addition of BLE functionality is limited to wireless transfer of stored measurement data and does not affect blood pressure measurement, analysis, display, or device operation. Verification and validation testing confirmed that the BLE functionality performs as intended and does not adversely impact device safety, effectiveness, or essential performance. Any additional differences are limited to user interface, ergonomic, and interoperability enhancements and do not raise new questions of safety or effectiveness. Accordingly, the BP7155D is substantially equivalent to the predicate device. K261929 Page 9 of 9