Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Whill, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
116 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | 2026-06-12 | 63 | 0 |
| K242760 | WHILL Model R | Whill, Inc. | 2025-01-06 | 116 | 0 |
| K221438 | WHILL Model F | Whill, Inc. | 2022-06-07 | 21 | 1 |
| K213383 | WHILL Model C2 | Whill, Inc. | 2021-11-09 | 27 | 1 |
| K153543 | WHILL Model M | Whill, Inc. | 2016-02-12 | 63 | 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