# Withings

- Location (FDA's records): Issy-Les-Moulineaux, FR
- FDA decisions: 8 (2011–2025): 8 510(k) clearances
- Names in FDA's records: Withings (7); Withings SA (1)
- Product codes: DPS (3), DXN (2), FLL (1), QDA (1), MNR (1)
- 510(k) review time since 2016: median 152 days, against 163 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- AliveCor, Inc.: 2 (https://510kreport.com/company/alivecor)
- Andon Health Co, Ltd.: 2 (https://510kreport.com/company/andon-health)
- Ya Horng Electronic Co., Ltd.: 1 (https://510kreport.com/company/ya-horng-electronic)
- Tyto Care, Ltd.: 1 (https://510kreport.com/company/tyto-care)
- Kaz USA, Inc (A Subsidiaryof Kaz Inc): 1 (https://510kreport.com/company/kaz-usa-a-subsidiaryof-kaz)
- Apple, Inc.: 1 (https://510kreport.com/company/apple)
- Resonea, Inc.: 1 (https://510kreport.com/company/resonea)

## Firms that cite its devices most
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Cardiacsense: 1 (https://510kreport.com/company/cardiacsense)
- Visiomed Group SA: 1 (https://510kreport.com/company/visiomed-group)
- Amzetta Technologies Private Limited: 1 (https://510kreport.com/company/amzetta-technologies-private)

## Its most-cited devices
- K201456: Scan Monitor (2021), cited by 4
- K133125: Withings Blood Presure Monitor (2014), cited by 2
- K110872: Withings Blood Pressure Monitor (2011), cited by 1
- K160544: Withings Thermo (Model SCT01) (2016), cited by 1

## Recent decisions
- K252474: Withings BeamO (SCT02) (Nov 10, 2025)
- K240795: Withings ECG App (Jun 15, 2025)
- K231667: Withings Sleep Rx (Sep 6, 2024)
- K230812: Withings Scan Monitor 2.0 (Aug 23, 2023)
- K201456: Scan Monitor (Oct 5, 2021)
- K160544: Withings Thermo (Model SCT01) (Jun 17, 2016)
- K133125: Withings Blood Presure Monitor (Mar 24, 2014)
- K110872: Withings Blood Pressure Monitor (May 20, 2011)

Source page: https://510kreport.com/company/withings