Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1130](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1130) → DXN — System, Measurement, Blood-Pressure, Non-Invasive # DXN · System, Measurement, Blood-Pressure, Non-Invasive _Cardiovascular · 21 CFR 870.1130 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN ## Overview - **Product Code:** DXN - **Device Name:** System, Measurement, Blood-Pressure, Non-Invasive - **Regulation:** [21 CFR 870.1130](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1130) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## 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. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 1207) Showing 20 most recent of 1207 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260276](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K260276.md) | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. | Apr 1, 2026 | SESE | | [K254225](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K254225.md) | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. | Apr 1, 2026 | SESE | | [K260273](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K260273.md) | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | Mar 26, 2026 | SESE | | [K252779](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K252779.md) | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Mar 5, 2026 | SESE | | [K253228](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K253228.md) | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Feb 23, 2026 | SESE | | [K253133](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K253133.md) | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | Feb 13, 2026 | SESE | | [K252685](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K252685.md) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | Joytech Healthcare Co. , Ltd. | Feb 13, 2026 | SESE | | [K251581](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K251581.md) | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | Feb 13, 2026 | SESE | | [K251307](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K251307.md) | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | Jan 12, 2026 | SESE | | [K253142](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K253142.md) | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | Ningbo Ranor Medical Technology Co., Ltd. | Jan 9, 2026 | SESE | | [K251143](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K251143.md) | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | Dec 19, 2025 | SESE | | [K251331](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K251331.md) | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | Oct 27, 2025 | SESE | | [K251795](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K251795.md) | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Honsun (Nantong) Co., Ltd. | Oct 9, 2025 | SESE | | [K252769](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K252769.md) | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | Shenzhen Finicare Co., Ltd. | Oct 2, 2025 | SESE | | [K250231](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K250231.md) | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | Dongguan E-Test Technology Co., Ltd. | Sep 3, 2025 | SESE | | [K251120](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K251120.md) | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) | Microlife Corporation | Aug 6, 2025 | SESE | | [K251113](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K251113.md) | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr | Andon Health Co, Ltd. | Aug 4, 2025 | SESE | | [K244007](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K244007.md) | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch | Jul 30, 2025 | SESE | | [K251102](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K251102.md) | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) | Cemho Medical Technology (Guangdong) Co., Ltd. | Jul 16, 2025 | SESE | | [K250185](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K250185.md) | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | Jiangxi Aicare Medical Technology Co., Ltd. | Jul 14, 2025 | SESE | ## Top Applicants - Andon Health Co, Ltd. — 68 clearances - Health & Life Co., Ltd. — 55 clearances - Omron Healthcare, Inc. — 36 clearances - Microlife Intellectual Property GmbH — 33 clearances - A&D Engineering, Inc. — 25 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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