Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION January 12, 2026 Shenzhen Hingmed Medical Instrument Co., Ltd. Huang Yongban RA Manager 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District Shenzhen, Guangdong 518102 China Re: K251307 Trade/Device Name: Clinical Automatic Blood Pressure Monitor (DBP-20, DBP-20i) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 11, 2025 Received: December 11, 2025 Dear Huang Yongban: 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 &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251307 - Huang Yongban 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K251307 - Huang Yongban Page 3 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 LCDR 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} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | 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) K251307 | | | Device Name Clinical Automatic Blood Pressure Monitor (DBP-20, DBP-20i) | | | Indications for Use (Describe) This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose. Environments of use: Hospital and other medical establishment(contraindicate the home as an environment of use). Patient population: Adult (exclude pregnant women ). | | | 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." | | {4} K251307 # 510(k) Summary This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. # 1. Submitter's Information 510(k) Owner's Name: Shenzhen Hingmed Medical Instrument Co., Ltd Establishment Registration Number: Applying Address: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen,,GuangDong, People's Republic of China Tel: +86-0755-232069446 Contact Person (including title): Yongban Huang (Manger Representative) E-mail: hyb@hingmed.com # 2. Subject Device Information Type of 510(k): Traditional Common Name: Noninvasive blood pressure measurement system Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Trade Name: Clinical Automatic Blood Pressure Monitor Model Name: DBP-20,DBP-20i Review Panel: Cardiovascular Product Code: DXN Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II # 3. Predicate Device Information | Sponsor | Shenzhen Hingmed Medical Instrument Co., Ltd | | --- | --- | | Device Name | Clinical Automatic Blood Pressure Monitor | | Model or type Name | DBP-01HP,DBP-01P | | 510(k) Number | K231984 | | Product code | DXN | {5} K251307 | Regulation Number | 21 CFR 870.1130 | | --- | --- | | Regulation class | Class II | # 4. Indications for Use This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate, and the physician reference the result to diagnose. Environments of use: Hospital and other medical establishment(contraindicate the home as an environment of use) Patient population: Adult (exclude pregnant women) # 5. Device Description Clinical Automatic blood pressure monitor have two types that is DBP-20 and DBP-20i. The Clinical Automatic blood pressure monitor is used to measure the blood pressure of adult in hospital or other medical establishment. It's contain of main body, power adapter. The device can show the time and measure result. There is a difference DBP-20 and DBP -20i. The difference is the function with voice broadcast. DBP-20i have the function which broadcast the measure result. and DBP-20 have not the broadcasting function. Clinical Automatic Blood Pressure Monitor is intended to be used for arms range from 17 to $42\mathrm{cm}$ in circumference. The cuff cover can be replace easily. The device intended use at medical center.  Photo of DBP-20 &amp;DBP-20i  {6} K251307 6. Substantial Equivalence table | Device | Subject Device | Predicate Device | Remarks | | --- | --- | --- | --- | | Manufacture | Shenzhen Hingmed Medical Instrument Co., Ltd | Shenzhen Hingmed Medical Instrument Co., Ltd | NA | | Model | DBP-20,DBP-20i | DBP-01P,DBP-01HP | NA | | classification | II | II | Same | | Product code | DXN | DXN | Same | | Regulation No. | 870.1130 | 870.1130 | Same | | 510(K) number | N/A | N/A | NA | | Intended use/ Indicate for use | This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose | This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose | Same | | Environmental of use | Hospital and other medical establishment | Hospital and other medical establishment | Same | | Patient population | Adult (exclude pregnant women ) | Adult (exclude pregnant women ) | Same | | Measurement site | Upper Arm | Upper Arm | Same | | Measurement method | Oscillometric method | Oscillometric method | Same | | Measurement range | Pressure:0 to 290 Pulse rate:40 to 200bpm | Pressure:0 to 289 Pulse rate:40 to 200bpm | Difference | | Measuring accuracy | Pressure:within ±3mmHg Pulse Rate: whichever is grater(±3bpm or±3%) | Pressure:within ±3mmHg Pulse Rate: whichever is grater(±3bpm or±3%) | Same | | Cuff | 17-42cm | 17-42cm | Same | | Inflation | Automatic internal pump | Automatic internal pump | Same | | Deflation | Automatic rapid deflation | Automatic rapid deflation | Same | | Power source | mains | mains | Same | | Protection against electrical shock | Class I, Type B | Class I, Type B | Same | | Display | LCD display | LCD display or LED display | same | | Operation Environment condition | 5°C-40°C; RH: 10%-95%; non-condensing,atmospheric pressure(70KPa-106Kpa) | 5°C-40°C; RH: 10%-95%; non-condensing,atmospheric pressure(70KPa-106Kpa) | same | | Storage Environment | -20°C- 55°C, RH≤90% (non-condensing) | -20°C- 55°C, RH≤90% (non-condensing) | same | Page 3 of 4 {7} K251307 | Condition | 70KPa-106Kpa | 70KPa-106Kpa | | | --- | --- | --- | --- | | Weight | About 4.5Kg | About 6Kg | Similar | | Dimension(L* D*H) | About :390(L)×210(W)×320(H)mm | About W:310×L:478×H:300mm | Similar | | Patient contact materials | Surface contact Skin Limited duration of use<24 hours | Surface contact Skin Limited duration of use<24 hours | Same | # 5. non-clinical Test Summary Clinical Automatic blood pressure monitor has been evaluated the safety and performance by lab bench testing, as following: Electrical safety test according to IEC 60601-1 and IEC 80601-2-30 standards Electromagnetic compatibility test according to IEC 60601-1-2 standard # 6. Brief discussions of clinical tests ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type; In this clinical investigation, The DBP-20i was tested in 90 subjects from the general population (mean age, 41.3 years; 45 men) using a wide-range cuff for arm circumferences from 17 to 42 cm. The mean device-observer difference was 3.71±3.44 mmHg for SBP and 3.21±3.54 mmHg for DBP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5±8 mmHg). Also, criterion 2 was satisfied with the SDs of the 90 participants being well below the maximum values required by the protocol (5.83 and 6.03 mmHg for SBP and DBP pressure, respectively). The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2 # 7. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, mode of operation, and intended use of clinical automatic blood pressure monitor is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not rise new issues of safety or effectiveness. # 8. Conclusion Non-clinical performance was conducted on the subject device and all tests met specified criteria. Based on the information provided in this submission, the Clinical Automatic blood pressure monitor is substantially equivalent to the predicate device, Clinical Automatic blood pressure monitor. Page 4 of 4