Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Withings — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
152 daysmedian FDA review time
457 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252474 | Withings BeamO (SCT02) | Withings | 2025-11-10 | 96 | 0 |
| K240795 | Withings ECG App | Withings | 2025-06-15 | 450 | 0 |
| K231667 | Withings Sleep Rx | Withings | 2024-09-06 | 457 | 0 |
| K230812 | Withings Scan Monitor 2.0 | Withings | 2023-08-23 | 152 | 0 |
| K160544 | Withings Thermo (Model SCT01) | Withings | 2016-06-17 | 112 | 0 |
| K133125 | WITHINGS BLOOD PRESURE MONITOR | Withings | 2014-03-24 | 175 | 0 |
| K110872 | WITHINGS BLOOD PRESSURE MONITOR | Withings | 2011-05-20 | 52 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda