Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OXC — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
219 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery, LLC | 2026-01-09 | 119 | 0 |
| K231603 | Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. | 2023-10-06 | 127 | 0 |
| K221343 | ECHELON ENDOPATH Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | 2022-09-16 | 130 | 0 |
| K221487 | NEOVEIL Staple Line Reinforcement | Gunze Limited | 2022-08-26 | 95 | 0 |
| K190937 | Echelon Endopath Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | 2019-10-14 | 187 | 0 |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | W. L. Gore & Associates, Inc. | 2018-08-17 | 29 | 0 |
| K150551 | GORE SEAMGUARD Reinforcement | W. L. Gore & Associates, Inc. | 2015-03-30 | 26 | 0 |
| K130997 | NEOVEIL | Gunze Limited | 2013-11-15 | 219 | 0 |
| K131658 | GORE SEAMGUARD REINFORCEMENT | W. L. Gore & Associates, Inc. | 2013-09-06 | 92 | 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