Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
E.W.A., Ltd. — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943339 | GAUZE SPONGE (E.W.A. LTD./VARIOUS) | E.W.A., Ltd. | 1994-08-23 | 42 | 0 |
| K923378 | USP TYPE VII GAUZE SPONGES | E.W.A., Ltd. | 1992-10-06 | 89 | 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