Company ยท FR
Withings
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 10, 2025 | K252474 | Withings BeamO (SCT02) Withings, FR | DPS |
| Jun 15, 2025 | K240795 | Withings ECG App Withings, FR | QDA |
| Sep 6, 2024 | K231667 | Withings Sleep Rx Withings, FR | MNR |
| Aug 23, 2023 | K230812 | Withings Scan Monitor 2.0 Withings, FR | DPS |
| Oct 5, 2021 | K201456 | Scan Monitor Withings SA, FR | DPS |
| Jun 17, 2016 | K160544 | Withings Thermo (Model SCT01) Withings, FR | FLL |
| Mar 24, 2014 | K133125 | WITHINGS BLOOD PRESURE MONITOR Withings, FR | DXN |
| May 20, 2011 | K110872 | WITHINGS BLOOD PRESSURE MONITOR Withings, TW | DXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2023 | Withings Scan Monitor/ScanWatch, model number hwa09
Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2) Open, Classified |
DPS | K201456 |
| Jun 11, 2018 | Withings Sas Nokia BPM+ Wireless Blood Pressure Monitor
Product System, measurement, blood-pressure, non-invasive Completed |
DXN | K133125 |