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/productcode/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 1214) Showing 20 most recent of 1214 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253124](/device/K253124.md) | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | Jun 3, 2026 | SESE | | [K253570](/device/K253570.md) | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | May 20, 2026 | SESE | | [K254048](/device/K254048.md) | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | Shenzhen Urion Technology Co., Ltd. | May 14, 2026 | SESE | | [K253152](/device/K253152.md) | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | May 6, 2026 | SESE | | [K260260](/device/K260260.md) | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | Apr 28, 2026 | SESE | | [K252501](/device/K252501.md) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. | Apr 28, 2026 | SESE | | [K253982](/device/K253982.md) | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | Apr 21, 2026 | SESE | | [K260276](/device/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](/device/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](/device/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](/device/K252779.md) | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Mar 5, 2026 | SESE | | [K253228](/device/K253228.md) | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Feb 23, 2026 | SESE | | [K253133](/device/K253133.md) | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | Feb 13, 2026 | SESE | | [K252685](/device/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](/device/K251581.md) | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | Feb 13, 2026 | SESE | | [K251307](/device/K251307.md) | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | Jan 12, 2026 | SESE | | [K253142](/device/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](/device/K251143.md) | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | Dec 19, 2025 | SESE | | [K251331](/device/K251331.md) | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | Oct 27, 2025 | SESE | | [K251795](/device/K251795.md) | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Honsun (Nantong) Co., Ltd. | Oct 9, 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/productcode/DXN](https://fda.innolitics.com/productcode/DXN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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