Withings: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Withings” (first 2011, latest 2025), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 152 days. Since 2017 the median was 301 days, against 186 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 175 |
| 2015 | 0 | — |
| 2016 | 1 | 112 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 152 |
| 2024 | 1 | 457 |
| 2025 | 2 | 273 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Withings took a median 301 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | 1 | 1 |
Review panels
- Cardiovascular (5)
- Anesthesiology (1)
- General Hospital (1)
Most recent Withings 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252474 | Withings BeamO (SCT02) | DPS | 2025-11-10 | 96 |
| K240795 | Withings ECG App | QDA | 2025-06-15 | 450 |
| K231667 | Withings Sleep Rx | MNR | 2024-09-06 | 457 |
| K230812 | Withings Scan Monitor 2.0 | DPS | 2023-08-23 | 152 |
| K160544 | Withings Thermo (Model SCT01) | FLL | 2016-06-17 | 112 |
| K133125 | WITHINGS BLOOD PRESURE MONITOR | DXN | 2014-03-24 | 175 |
| K110872 | WITHINGS BLOOD PRESSURE MONITOR | DXN | 2011-05-20 | 52 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-12-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Withings is the lead sponsor of 14 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT07595016: Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-eclampsia (Recruiting, started 2026-05-11)
- NCT06957847: Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 (WIHYP-GP) (Completed, started 2025-04-28)
- NCT07430878: Smart Devices-based Longitudinal Assessment of Patterns of Insomnia (Enrolling by invitation, started 2025-02-18)
- NCT06351761: WIBOFA - Validation of SCT02 With ECG-App for Detection of AF (Completed, started 2024-06-03)
- NCT05316350: Withings ECG-app Study (Completed, started 2022-07-15)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Withings SA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Withings?
FDA lists 7 510(k) clearances under the applicant name “Withings” (first 2011, latest 2025), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Withings?
The median time from FDA receipt to decision across 510(k)s cleared under the name Withings is 152 days. Since 2017: 301 days, versus 186 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Withings?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 7 Withings clearances with predicates and recalls
- Run predicate analysis for product code DPS, Withings's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.