Wrist Type Blood Pressure Monitor
FDA 510(k) K200346 · Avita Corporation
510(k) numberK200346
Submission
- Device name
- Wrist Type Blood Pressure Monitor
- Applicant
- Avita Corporation
New Taipei City, TW - Received
- February 11, 2020
- Decision date
- December 17, 2020
- 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 |
|---|---|---|
| K250129 | AViTA Breast PumpHGX · Traditional | 06/11/2026SE |
| K252448 | AViTA Pulse Oximeter (SP61)DQA · Traditional | 02/27/2026SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | 09/03/2025SE |
| K242455 | AViTA Pulse Oximeter (SP62B)DQA · Traditional | 02/19/2025SE |
| K241852 | Nasal Aspirator (NS 13)BTA · Traditional | 12/31/2024SE |
| K242193 | Arm Type Blood Pressure Monitor (BPM82)DXN · Traditional | 10/22/2024SE |
| K223399 | AViTA Pulse OximeterDQA · Traditional | 05/20/2024SE |
| K180155 | Arm Type Blood Pressure MonitorDXN · Traditional | 08/03/2018SE |
| K172427 | AViTA Radar Thermo NT16 Series IR ThermometerFLL · Traditional | 04/19/2018SE |
| K112825 | Avita Arm Type Blood Pressure MonitorDXN · Traditional | 01/18/2012SE |
Questions and answers
When was Wrist Type Blood Pressure Monitor cleared by the FDA?
Wrist Type Blood Pressure Monitor (K200346) received a 510(k) decision of Substantially Equivalent on December 17, 2020, 310 days after the submission was received.
What is the product code of K200346?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.