YUWELL Electronic Blood Pressure Monitor
FDA 510(k) K221372 · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
510(k) numberK221372
Submission
- Device name
- YUWELL Electronic Blood Pressure Monitor
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Danyang, CN - Received
- May 12, 2022
- Decision date
- October 17, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
More from 80 Beats Medical GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K261571 | Manual Wheelchair (H008, PCK7)IOR · Traditional | 08/06/2026SE |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR)DXN · Traditional | 03/05/2026SE |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR)DXN · Traditional | 02/23/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | 02/17/2026SE |
| K242736 | Portable Oxygen Concentrator (Spirit-3)CAW · Traditional | 06/05/2025SE |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL · Traditional | 05/22/2025SE |
| K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5ACAW · Traditional | 04/28/2023SE |
| K212385 | YUWELL Finger Pulse OximeterDQA · Traditional | 08/16/2022SE |
| K203583 | YUWELL infrared ear thermometer: YHT101, YHT200FLL · Traditional | 05/20/2021SE |
| K201864 | YUWELL Infrared ThermometerFLL · Traditional | 12/07/2020SE |
Questions and answers
When was YUWELL Electronic Blood Pressure Monitor cleared by the FDA?
YUWELL Electronic Blood Pressure Monitor (K221372) received a 510(k) decision of Substantially Equivalent on October 17, 2022, 158 days after the submission was received.
What is the product code of K221372?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.