Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Westaim Biomedical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
342 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010447 | MODIFICATION TO ACTICOAT FOAM DRESSING | Westaim Biomedical, Inc. | 2001-03-15 | 30 | 0 |
| K002466 | ACTICOAT COMPOSITE DRESSING | Westaim Biomedical, Inc. | 2001-02-16 | 189 | 0 |
| K001519 | ACTICOAT 7 DRESSING | Westaim Biomedical, Inc. | 2000-10-06 | 143 | 0 |
| K992221 | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING | Westaim Biomedical, Inc. | 2000-06-07 | 342 | 0 |
| K000051 | ACTICOAT FOAM DRESSING | Westaim Biomedical, Inc. | 2000-04-05 | 89 | 1 |
| K983833 | ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND | Westaim Biomedical, Inc. | 1998-12-10 | 41 | 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