Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OOD — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
183 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233999 | GalaFLEX LITE Scaffold | Tepha, Inc. | 2024-04-09 | 113 | 0 |
| K202425 | SurgiLattice scaffold | Tepha, Inc. | 2021-08-19 | 359 | 0 |
| K162922 | GalaFORM 3D | Tepha, Inc. | 2017-02-23 | 128 | 0 |
| K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016-09-29 | 129 | 0 |
| K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016-08-23 | 127 | 0 |
| K142818 | Phasix Mesh | C. R. Bard | 2015-03-31 | 183 | 0 |
| K140533 | GALAFLEX MESH | Tepha, Inc. | 2014-05-21 | 78 | 0 |
| K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | Tepha, Inc. | 2013-05-07 | 88 | 0 |
| K113721 | TEPHAFLEX LIGHT MESH | Tepha, Inc. | 2012-02-15 | 58 | 0 |
| K113723 | TEPHAFLEX MESH | Tepha, Inc. | 2012-02-15 | 58 | 0 |
| K111946 | TEPHAFLEX MESH | Tepha, Inc. | 2011-09-26 | 80 | 0 |
| K091633 | TEPHAFLEX SURGICAL FILM | Tepha, Inc. | 2009-08-07 | 64 | 0 |
| K070894 | TEPHAFLEX SURGICAL MESH | Tepha, Inc. | 2007-04-13 | 14 | 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