← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K253142 # Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (K253142) _Ningbo Ranor Medical Technology Co., Ltd. · DXN · Jan 9, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K253142 ## Device Facts - **Applicant:** Ningbo Ranor Medical Technology Co., Ltd. - **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md) - **Decision Date:** Jan 9, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy. ## Device Story Automatic non-invasive blood pressure monitor; uses inflatable cuff wrapped around upper arm; powered by dry batteries. Principle of operation: oscillometric method; electronic pump for inflation; automatic pressure release valve for deflation. Device measures systolic/diastolic blood pressure and pulse rate. Features include 60-group memory for two users, average reading calculation, and optional voice broadcast. Used in home environment by patients; no physician operation required. Output displayed on segment LCD/LED screen. Data informs patient of blood pressure status; assists in monitoring health trends. Identical software, algorithm, and core components across all models (MJ1D, MJ1DS, MJ3D, MJ5D, MJ6D, MJ8D, RN3D, MJ4D, RN1D, RN2D). ## Clinical Evidence Bench testing only. No clinical data provided. Device performance verified against IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 80601-2-30. Biocompatibility of patient-contacting materials (Nylon TPU) supported by previous testing in K193456. ## Technological Characteristics Oscillometric measurement; electronic pump/valve actuation. Materials: Nylon TPU cuff (ISO 10993 compliant). Power: 4 AAA batteries. Connectivity: None. Form factor: Arm-worn cuff with main unit. Software: Embedded firmware, identical to K193456. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30. ## 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 - Arm Blood Pressure Monitor, RN-032A, RN-032C ([K193456](/device/K193456.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} FDA U.S. FOOD & DRUG ADMINISTRATION January 9, 2026 Ningbo Ranor Medical Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lu Jiazui Rd., Pudong Shanghai, 200120 China Re: K253142 Trade/Device Name: Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: September 25, 2025 Received: September 25, 2025 Dear Boyle Wang: 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} K253142 - Boyle Wang 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. {2} K253142 - Boyle Wang Page 3 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, HETAL B. ODOBASIC -S for Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: 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. | K253142 | ? | | Please provide the device trade name(s). | | ? | | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | | | | Please provide your Indications for Use below. | | ? | | The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy. | | | | Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) Summary # 510(k) Summary # K253142 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92. ## 1.0 Submitter's Information Name: Ningbo Ranor Medical Science & Technology Co., Ltd. Address: No. 127 Fenghui Road, Wangchun Industrial Park, Haishu District, Ningbo, China Tel: 86-574-89258788 Contact: Xu Jia'nan ## Designated Submission Correspondent Contact: Mr. Boyle Wang Name: Shanghai Truthful Information Technology Co., Ltd. Address: Room 1801, No. 161 East Lu Jiazui Rd., Pudong, Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn Date of Preparation: Dec.10,2025 ## 2.0 Device Information Trade name: Arm Blood Pressure Monitor Common name: Noninvasive Blood Pressure Measurement System Classification name: Noninvasive Blood Pressure Measurement System Model(s): MJ1D、MJ1DS、MJ3D、MJ5D、MJ6D、MJ8D、RN3D、MJ4D、RN1D、RN2D Production code: DXN Regulation number: 21 CFR 870.1130 Classification: Class II Panel: Cardiovascular ## 3.0 Predicate Device Information Manufacturer: Ningbo Ranor Medical Science & Technology Co., Ltd. Trade/Device name: Arm Blood Pressure Monitor, RN-032A, RN-032C Page 1 of 5 {5} 510(k) Summary 510(k) number: K193456 ## 4.0 Indication for Use Statement The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy. ## 5.0 Device Description The subject device, Arm Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by dry batteries. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy. The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate. This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results. This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips. No operation for 1 minute the device will shut down automatically. The subject device includes model MJ1DS/MJ1D/MJ3D/MJ5D/MJ6D/MJ8D/RN3D/MJ4D/RN1D/RN2D. These models are identical in terms of software design, cuff type, measurement range and function, principle, the core algorithm of the software, the key components. The schematic circuit diagrams are identical in all models. The PCB layout are identical in all models because of different appearance such as structure, buttons layout. ## 6.0 Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - IEC 60601-1:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. {6} 510(k) Summary - 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 - 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. ## Biocompatibility Testing The proposed Arm Blood Pressure Monitor does not introduce any new direct or indirect patient contacting materials including new color additive, as compared to the previous clearance predicate Arm Blood Pressure Monitor. So the biocompatibility testing reports provided and reviewed in K193456 remain valid and can support the subject Arm Blood Pressure Monitor. ## Software Verification and Validation Testing The subject devices utilize the same software version, software algorithm, measurement logic and functionality as the cleared predicate devices (RN-032A and RN-032C, K193456). No code changes or new functions were introduced. The software safety classification remains unchanged. The verification and validation testing previously reviewed in K193456 continues to support the subject devices, as the software operates identically to the predicate. Therefore, no additional software verification and validation testing is required to demonstrate substantial equivalence. ## 7.0 Clinical Test Conclusion As the subject device utilizes the same monitoring technology as the predicate device, there is no change on the sensors, cuffs, algorithms, measurement accuracy of the subject device, additional testing was not considered necessary to support the substantial equivalence. ## 8.0 Technological Characteristic Comparison Table {7} 510(k) Summary Table1-General Comparison | Item | Subject Device K253142 | Predicate Device K193456 | Remark | | --- | --- | --- | --- | | Manufacturer | Ningbo Ranor Medical Science & Technology Co., Ltd. | Ningbo Ranor Medical Science & Technology Co., Ltd. | / | | Product Name | Arm Blood Pressure Monitor MJ1D、MJ1DS、MJ3D、MJ5D、MJ6D、MJ8D、RN3D、MJ4D、RN1D、RN2D | Arm Blood Pressure Monitor RN-032A,RN-032C | / | | Product Code | DXN | DXN | Same | | Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same | | Class | II | II | Same | | Intended Use/Indication for Use | The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy. | The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy. | Same | | Application Site | Upper Arm | Upper Arm | Same | | Arm Circumference | 22cm ~ 32cm | 220mm ~ 320mm | Same | | Patients Contacting Materials | Patient contact materials of the cuff: Nylon TPU (Cuff) According to ISO-10993 | Patient contact materials of the cuff: Nylon TPU (Cuff) According to ISO-10993 | Same | | Patient Population | Adult | Adult | Same | | Measurements Item | SYS,DYS,Pulse | SYS,DYS,Pulse | Same | | Display | Segment LCD Display, Segment LED Display(MJ1DS) | Segment LCD Display | Same | | Design Method | Oscillometric Method | Oscillometric Method | Same | Table 2 Performance Comparison | Item | Subject Device K253142 | Predicate Device K193456 | Remark | | --- | --- | --- | --- | | Max Cuff pressure | 294 mmHg | 300mmHg | Different | | BP Range | Systolic: 60–249 mmHg Diastolic: 30–170 mmHg | 0 ~ 299 mmHg | | | BP Accuracy | ±3 mmHg | ±3 mmHg | Same | | PR Range | 40-190 beats/min | 40 ~ 180 beats/min | Different | | Pulse Accuracy | ±5% of reading value | ±5% of reading value | Same | | Inflation Method | Automatic by electronic pump | Automatic by electronic pump | Same | | Deflation Method | Automatic Pressure Release Valve | Automatic Pressure Release Valve | Same | Page 4 of 5 {8} 510(k) Summary | Memory Size | 2x60 sets of data | 2x60 sets of data | Same | | --- | --- | --- | --- | | Operation Condition | 5-40 °C 15%-80% RH 80kPa~106kPa | 5~40°C, Humidity: 15%-80% Atmospheric: 80kPa~106kPa | Same | | Storage Condition | -20°C~55 °C Humidity: ≤95% (noncondensing) 50kPa~106kPa | -20°C~55°C, ≤95% (noncondensing) 50kPa~106kPa | Same | | Power Supply | 4 AAA dry batteries | 4 AAA dry batteries | Same | | Performance Standard | Comply with IEC 80601-2-30 | Comply with IEC 80601-2-30 | Same | Table 3 Safety Comparison | Item | Subject Device K253142 | Predicate Device K193456 | Remark | | --- | --- | --- | --- | | Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same | | Home Use | Comply with IEC 60601-1-11 | Comply with IEC 60601-1-11 | Same | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | | Biocompatibility | Comply with ISO 10993-1, FDA Guidance | Comply with ISO 10993-1, FDA Guidance | Same | ## 9.0 Conclusion The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness. Page 5 of 5 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K253142](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K253142) **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