DXN · System, Measurement, Blood-Pressure, Non-Invasive
Cardiovascular · 21 CFR 870.1130 · Class 2
Overview
| Product Code | DXN |
|---|---|
| Device Name | System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | Jun 3, 2026 | SESE |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | May 20, 2026 | SESE |
| K254048 | 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 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | May 6, 2026 | SESE |
| K260260 | 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 | 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 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | Apr 21, 2026 | SESE |
| K260276 | 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 | 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 | 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 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Mar 5, 2026 | SESE |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Feb 23, 2026 | SESE |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | Feb 13, 2026 | SESE |
| K252685 | 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 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | Feb 13, 2026 | SESE |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | Jan 12, 2026 | SESE |
| K253142 | 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 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | Dec 19, 2025 | SESE |
| K251331 | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | Oct 27, 2025 | SESE |
| K251795 | 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
