Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OWT — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
132 daysmedian FDA review time
269 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025-02-19 | 132 | 0 |
| K233661 | Transorbâ„¢ Self-Gripping Resorbable Mesh | Sofradim Production | 2024-02-13 | 90 | 0 |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020-03-26 | 269 | 0 |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2019-07-31 | 29 | 0 |
| K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019-06-12 | 131 | 0 |
| K173143 | Phasix ST Mesh | C.R. Bard, Inc. | 2018-04-25 | 208 | 0 |
| K163005 | TIGR Matrix Surgical Mesh | Novus Scientific AB | 2017-07-27 | 272 | 0 |
| K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015-06-05 | 192 | 0 |
| K120728 | PHASIX PLUG AND PATCH | C.R. Bard, Inc. | 2012-10-22 | 227 | 0 |
| K101287 | TEPHAFLEX COMPOSITE MESH | Tepha, Inc. | 2010-08-30 | 115 | 0 |
| K033671 | GORE BIOABSORBABLE MESH | W. L. Gore & Associates, Inc. | 2003-12-31 | 37 | 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