Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rti Biologics, Inc. · 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) |
|---|---|---|---|---|---|
| K123356 | FORTIVA PORCINE DERMIS | Rti Biologics, Inc. | 2013-03-05 | 125 | 0 |
| K091142 | TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 6835 | Rti Biologics, Inc. | 2009-08-31 | 133 | 0 |
| K081538 | TUTOPATCH, TUTOMESH | Rti Biologics, Inc. | 2008-06-19 | 17 | 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