Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
PSQ — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
147 daysmedian FDA review time
315 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221032 | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | 2022-10-19 | 195 | 1 |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2022-10-19 | 195 | 1 |
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | 2021-12-21 | 319 | 0 |
| K200566 | ADAPT Tissue | Admedus Regen Pty, Ltd. | 2020-04-03 | 30 | 0 |
| K190882 | XenoSure Biologic Patch | Lemaitre Vascular | 2020-02-13 | 315 | 0 |
| K191734 | MatriStem UBM Pericardial Patch | Acell, Inc. | 2019-11-22 | 147 | 0 |
| K183635 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2019-02-14 | 50 | 0 |
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Co | Cormatrix Cardiovascular, Inc. | 2018-10-10 | 174 | 0 |
| K172085 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-12-04 | 146 | 0 |
| K172660 | Duravess bovine pericardial vascular patch | Edwards Lifesciences, LLC | 2017-11-17 | 73 | 0 |
| K170951 | CardioCel 3D | Admedus Regen Pty, Ltd. | 2017-04-28 | 28 | 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