Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OHA · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary | Artivion, Inc. | 2025-10-02 | 93 | 0 |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | Cryolife, Inc. | 2010-05-25 | 323 | 3 |
| 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 |
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