Withings Blood Presure Monitor
FDA 510(k) K133125 · Withings
510(k) numberK133125
Submission
- Device name
- Withings Blood Presure Monitor
- Applicant
- Withings
Issy Les Moulineaux, FR - Received
- September 30, 2013
- Decision date
- March 24, 2014
- 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 |
|---|---|---|
| K252474 | Withings BeamO (SCT02)DPS · Traditional | 11/10/2025SE |
| K240795 | Withings ECG AppQDA · Traditional | 06/15/2025SE |
| K231667 | Withings Sleep RxMNR · Traditional | 09/06/2024SE |
| K230812 | Withings Scan Monitor 2.0DPS · Traditional | 08/23/2023SE |
| K201456 | Scan MonitorDPS · Traditional | 10/05/2021SE |
| K160544 | Withings Thermo (Model SCT01)FLL · Traditional | 06/17/2016SE |
| K110872 | Withings Blood Pressure MonitorDXN · Traditional | 05/20/2011SE |
Questions and answers
When was Withings Blood Presure Monitor cleared by the FDA?
Withings Blood Presure Monitor (K133125) received a 510(k) decision of Substantially Equivalent on March 24, 2014, 175 days after the submission was received.
What is the product code of K133125?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.