Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OXE · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2017-04-28 | 29 | 0 |
| K153364 | Kerecis SecureMesh | Kerecis Limited | 2016-08-19 | 273 | 0 |
| K030879 | VERITAS COLLAGEN MATRIX | Synovis Surgical Innovations | 2003-04-24 | 35 | 0 |
| K022044 | SURGISIS STAPLE LINE REINFORCEMENT | Cook Biotech, Inc. | 2002-08-23 | 60 | 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