Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LWK · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946162 | 3M(TM) SURGICAL SLIPPER, 9660 SERIES | Wahl Clipper Corp. | 1995-01-24 | 36 | 0 |
| K910524 | SURGICAL CLIPPER | Baxter Healthcare Corp | 1991-03-28 | 49 | 0 |
| K874370 | SURGICAL PREP RAZOR | Derma-Safe Co. | 1987-11-13 | 18 | 0 |
| K874234 | SURGICAL PREP RAZOR, STRAIGHT TYPE | Derma-Safe Co. | 1987-11-02 | 18 | 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