Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pegasus Biologics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
239 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090288 | ORTHADAPT PR | Pegasus Biologics, Inc. | 2009-05-05 | 89 | 0 |
| K071425 | UNITE BIOMATRIX | Pegasus Biologics, Inc. | 2007-06-20 | 28 | 0 |
| K071065 | ORTHADAPT BIOIMPLANT | Pegasus Biologics, Inc. | 2007-05-04 | 18 | 0 |
| K061494 | DERMADAPT WOUND DRESSING | Pegasus Biologics, Inc. | 2006-09-21 | 113 | 0 |
| K043388 | PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH | Pegasus Biologics, Inc. | 2005-08-05 | 239 | 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