Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OXF · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
164 daysmedian FDA review time
269 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025-06-20 | 60 | 0 |
| K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | 2025-05-21 | 215 | 0 |
| K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024-05-23 | 269 | 0 |
| K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022-12-19 | 84 | 0 |
| K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018-04-05 | 164 | 0 |
| K172545 | SERI Contour | Sofregen Medical, Inc. | 2017-09-22 | 30 | 0 |
| K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017-02-10 | 86 | 0 |
| K123128 | SERI SURGICAL SCAFFOLD | Allergan | 2013-04-25 | 203 | 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