Cryolife, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Cryolife, Inc.” (first 2006, latest 2019), plus 2 PMA decisions, across 7 product codes in 2 review panels. Median 510(k) review time under this name: 144 days. Since 2017 the median was 146 days, against 164 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 315 |
| 2013 | 0 | — |
| 2014 | 1 | 269 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 164 |
| 2018 | 0 | — |
| 2019 | 1 | 50 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cryolife, Inc. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 3 | 3 |
| FTM | Mesh, Surgical | 3 | 3 |
| OHA | Heart Valve, More Than Minimally Manipulated Allograft | 3 | 3 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 2 | 2 |
| MNO | System, Laser, Transmyocardial Revascularization | 1 | 0 |
| MUQ | Glue, Surgical, Arteries | 1 | 0 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 | 1 |
Review panels
Most recent Cryolife, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183635 | PhotoFix Decellularized Bovine Pericardium | PSQ | 2019-02-14 | 50 |
| K172085 | PhotoFix Decellularized Bovine Pericardium | PSQ | 2017-12-04 | 146 |
| K162506 | PhotoFix Decellularized Bovine Pericardium | DXZ | 2017-03-09 | 182 |
| K132105 | PERCLOT TOPICAL | QSY | 2014-04-03 | 269 |
| K110581 | PROPATCH SOFT TISSUE REPAIR MATRIX | FTM | 2012-01-10 | 315 |
| K101587 | PROPATCH SOFT TISSUE REPAIR MATRIX | FTM | 2010-09-16 | 101 |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | DXZ | 2010-07-23 | 21 |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | OHA | 2010-05-25 | 323 |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | DXZ | 2009-08-07 | 65 |
| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | OHA | 2009-02-06 | 109 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P010003 | PMA | BIOGLUE SURGICAL ADHESIVE | 2001-12-03 |
| P970029 | PMA | TMR HOLMIUM LASER SYSTEM | 1999-02-11 |
Recalls
97 product recalls in 57 recall events; 1 initiated in the last five years. Most recent: 2021-10-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Cryolife, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03369977: BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients (Active not recruiting, started 2017-11-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cryolife, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Cryolife, Inc.” (first 2006, latest 2019), plus 2 PMA decisions, across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cryolife, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cryolife, Inc. is 144 days. Since 2017: 146 days, versus 164 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cryolife, Inc.?
The most frequent FDA product codes under this applicant name are DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 3); FTM (Mesh, Surgical, 3); OHA (Heart Valve, More Than Minimally Manipulated Allograft, 3).
Next steps
- See all 12 Cryolife, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXZ, Cryolife, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.