Arm Blood Pressure Monitor
FDA 510(k) K221913 · Alicn Medical Shenzhen, Inc.
510(k) numberK221913
Submission
- Device name
- Arm Blood Pressure Monitor
- Applicant
- Alicn Medical Shenzhen, Inc.
Shenzhen, CN - Received
- June 30, 2022
- Decision date
- October 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345…FLL · Traditional | 12/22/2023SE |
| K231050 | Arm Blood Pressure MonitorDXN · Traditional | 10/11/2023SE |
| K230649 | Arm Blood Pressure MonitorDXN · Traditional | 09/07/2023SE |
| K222248 | Infrared ThermometerFLL · Traditional | 06/07/2023SE |
| K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241FLL · Traditional | 05/12/2022SE |
| K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1…FLL · Traditional | 05/05/2022SE |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241…FLL · Traditional | 05/04/2022SE |
| K212877 | Arm Blood Pressure MonitorDXN · Traditional | 01/12/2022SE |
| K210564 | Infrared ThermometerFLL · Traditional | 01/07/2022SE |
| K210563 | Arm Blood Pressure MonitorDXN · Traditional | 10/15/2021SE |
Questions and answers
When was Arm Blood Pressure Monitor cleared by the FDA?
Arm Blood Pressure Monitor (K221913) received a 510(k) decision of Substantially Equivalent on October 12, 2022, 104 days after the submission was received.
What is the product code of K221913?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.