510(k) Report

FDA applicant

Withings

Issy-Les-Moulineaux, FR8 decisions2011–20252 recalls

FDA records 8 decisions for Withings (Issy-Les-Moulineaux, FR) from 2011 to 2025: 8 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 152 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Withings SA”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Withings’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2011: 12014: 12016: 12021: 12023: 12024: 12025: 2
2011high 2 (2025) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2022

2018: 12022: 1
2011high 1 (2018) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Withings by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DPSElectrocardiograph3decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • FLLContinuous Measurement Thermometer1decision
  • QDAElectrocardiograph Software For Over-The-Counter Use1decision
  • MNRVentilatory Effort Recorder1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 152 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 163 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201456Scan MonitorWithings SA · 20214cite it
  • K133125Withings Blood Presure MonitorWithings · 20142cite it
  • K110872Withings Blood Pressure MonitorWithings · 20111cites it
  • K160544Withings Thermo (Model SCT01)Withings · 20161cites it

What has FDA decided for it lately?

  • K252474Withings BeamO (SCT02)Withings · 2025
  • K240795Withings ECG AppWithings · 2025
  • K231667Withings Sleep RxWithings · 2024
  • K230812Withings Scan Monitor 2.0Withings · 2023
  • K201456Scan MonitorWithings SA · 20211 recall
  • K160544Withings Thermo (Model SCT01)Withings · 2016
  • K133125Withings Blood Presure MonitorWithings · 20141 recall
  • K110872Withings Blood Pressure MonitorWithings · 2011

All 7 as Withings →The one decision as Withings SA →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K201456Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch…Dec 19, 2022Class II
  • K133125Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure…Jun 11, 2018Class II