Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Winfield Laboratories, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973538 | N-TERFACE | Winfield Laboratories, Inc. | 1997-12-16 | 89 | 0 |
| K923602 | ABSORBENT PAD -- MODIFICATION | Winfield Laboratories, Inc. | 1992-12-07 | 145 | 0 |
| K872069 | KONTOUR ULTRA SOFT SPONGE #SS144.50 | Winfield Laboratories, Inc. | 1987-07-14 | 46 | 0 |
| K820198 | DERMA-AID | Winfield Laboratories, Inc. | 1982-03-05 | 39 | 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