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-staging.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 1225) Showing 20 most recent of 1225 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K261929](/device/K261929.md) | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | Sep 10, 2026 | SESE | | [K254000](/device/K254000.md) | Happy Health Blood Pressure Monitor | Happy Health, Inc. | Sep 3, 2026 | SESE | | [K262658](/device/K262658.md) | Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | Aug 31, 2026 | SESE | | [K261394](/device/K261394.md) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | JOYTECH Healthcare Co., Ltd. | Aug 26, 2026 | SESE | | [K261061](/device/K261061.md) | BP Go (BPP-855) | Wellvii, Inc. | Aug 13, 2026 | SESE | | [K253425](/device/K253425.md) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co. , Ltd. | Aug 13, 2026 | SESE | | [K261136](/device/K261136.md) | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | Jul 23, 2026 | SESE | | [K261082](/device/K261082.md) | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | Jul 23, 2026 | SESE | | [K253126](/device/K253126.md) | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | Jun 18, 2026 | SESE | | [K260693](/device/K260693.md) | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | Jun 16, 2026 | SESE | | [K253059](/device/K253059.md) | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | Jun 15, 2026 | SESE | | [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 | ## 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-staging.innolitics.com/productcode/DXN](https://fda-staging.innolitics.com/productcode/DXN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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