Withings
FDA Regulatory Profile
Withings appears in FDA public data with 2 recalls, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1280-2023, Class II) was initiated on December 19, 2022. Its most recent 510(k) clearance was granted on November 10, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1280-2023 | Class II | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records | December 19, 2022 |
| Z-2829-2018 | Class II | Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-inva | June 11, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252474 | Withings BeamO (SCT02) | November 10, 2025 |
| K240795 | Withings ECG App | June 15, 2025 |
| K231667 | Withings Sleep Rx | September 6, 2024 |
| K230812 | Withings Scan Monitor 2.0 | August 23, 2023 |
| K201456 | Scan Monitor | October 5, 2021 |
| K160544 | Withings Thermo (Model SCT01) | June 17, 2016 |
| K133125 | WITHINGS BLOOD PRESURE MONITOR | March 24, 2014 |
| K110872 | WITHINGS BLOOD PRESSURE MONITOR | May 20, 2011 |