Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cryolife, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
323 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183635 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2019-02-14 | 50 | 0 |
| K172085 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-12-04 | 146 | 0 |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-03-09 | 182 | 0 |
| K132105 | PERCLOT TOPICAL | Cryolife, Inc. | 2014-04-03 | 269 | 0 |
| K110581 | PROPATCH SOFT TISSUE REPAIR MATRIX | Cryolife, Inc. | 2012-01-10 | 315 | 0 |
| K101587 | PROPATCH SOFT TISSUE REPAIR MATRIX | Cryolife, Inc. | 2010-09-16 | 101 | 0 |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | Cryolife, Inc. | 2010-07-23 | 21 | 2 |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | Cryolife, Inc. | 2010-05-25 | 323 | 3 |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | Cryolife, Inc. | 2009-08-07 | 65 | 1 |
| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | Cryolife, Inc. | 2009-02-06 | 109 | 1 |
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG | Cryolife, Inc. | 2008-02-07 | 1556 | 2 |
| K061892 | PROPATCH SOFT TISSUE REPAIR MATRIX | Cryolife, Inc. | 2006-11-22 | 142 | 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