Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brennen Medical, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113866 | PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX | Brennen Medical, LLC | 2012-03-23 | 84 | 0 |
| K111436 | PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX | Brennen Medical, LLC | 2011-10-14 | 143 | 0 |
| K081272 | PORCINE SURGICAL MESH; DERMAL MATRIX | Brennen Medical, LLC | 2008-07-31 | 87 | 4 |
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