510(k) Report

FDA applicant

Cryolife, Inc.

Kennesaw, GA14 decisions1999–201920 recalls

FDA records 14 decisions for Cryolife, Inc. (Kennesaw, GA) from 1999 to 2019: 12 510(k) clearances and 2 original PMA approvals. Most are in product codes OHA (Heart Valve, More Than Minimally Manipulated…) and FTM (Mesh, Surgical). Its devices cite 14 predicates, 8 of them its own earlier devices. 20 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cryolife, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2008: 12009: 22010: 32012: 12014: 12017: 22019: 1
2007high 3 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008: 22011: 32013: 12014: 12016: 12017: 12018: 42020: 22021: 12024: 32026 (partial year): 1
2007high 4 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cryolife, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cryolife, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OHAHeart Valve, More Than Minimally Manipulated Allograft3decisions
  • FTMMesh, Surgical3decisions
  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene3decisions
  • PSQIntracardiac Patch Or Pledget, Biologically Derived2decisions
  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics1decision
  • MNOSystem, Laser, Transmyocardial Revascularization1decision

Also: MUQ (1).

Whose devices does it build on?

Its devices cite 14 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061892Propatch Soft Tissue Repair MatrixCryolife, Inc. · 20063cite it
  • K101587Propatch Soft Tissue Repair MatrixCryolife, Inc. · 20102cite it
  • K083106Cryovalve SG Pulmonary Valve and ConduitCryolife, Inc. · 20092cite it
  • K092021Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. · 20102cite it
  • K033484Human Heart Valve, Cryovalve SGCryolife, Inc. · 20081cites it
  • K172085PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 20171cites it

What has FDA decided for it lately?

  • K183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2019
  • K172085PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
  • K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
  • K132105Perclot TopicalCryolife, Inc. · 2014
  • K110581Propatch Soft Tissue Repair MatrixCryolife, Inc. · 2012
  • K101587Propatch Soft Tissue Repair MatrixCryolife, Inc. · 2010
  • K101866Cryopatch SG Pulmonary Human Cardiac PatchCryolife, Inc. · 20105 recalls
  • K092021Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. · 20105 recalls

All 14 as Cryolife, Inc. →

What has been recalled?

20 recalls linked to its devices; the latest:

  • K101866CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010Sep 18, 2026
  • K091626(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00…May 28, 2024Class II
  • K092021CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart…May 28, 2024Class II
  • K092021CryoValve SG Cryopreserved Pulmonary Human Heart ValveMar 6, 2024Class II
  • P010003BioGlue Surgical Adhesive, Model BG3510-5-GOct 7, 2021Class II
  • K101866CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue…Nov 10, 2020Class II