Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Collamatrix Co., 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) |
|---|---|---|---|---|---|
| K090894 | COLLAWOUND WOUND DRESSING | Collamatrix Co., Inc. | 2009-06-25 | 86 | 0 |
| K071557 | COLLAWOUND HYDROGEL | Collamatrix Co., Inc. | 2008-02-08 | 246 | 0 |
| K070269 | MODIFICATION TO COLLAWOUND DRESSING | Collamatrix Co., Inc. | 2007-03-02 | 32 | 0 |
| K061474 | COLLAWOUND DRESSING | Collamatrix Co., Inc. | 2006-07-05 | 36 | 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