# K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit)

- Pathway: 510(k) (Traditional)
- Applicant: Cryolife, Inc.
- Decided: May 25, 2010 after 323 days
- Product code: OHA (Heart Valve, More Than Minimally Manipulated Allograft)
- Device class: U
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033484 (2008). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033484: Human Heart Valve, Cryovalve SG, Cryolife, Inc. (2008) Summary page 1.
- K083106: Cryovalve SG Pulmonary Valve and Conduit, Cryolife, Inc. (2009) Summary page 1.

## Most influential descendants
- K252059: CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (2025), 0 descendants of its own
- K101866: Cryopatch SG Pulmonary Human Cardiac Patch (2010), 0 descendants of its own

## Recalls of this device
- May 28, 2024 · Class II · Z-2531-2024: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- Mar 6, 2024 · Class II · Z-1545-2024: The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- Nov 10, 2020 · Class II · Z-0652-2021: On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processin
- May 14, 2018 · Class II · Z-2271-2018: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
- Feb 17, 2011 · Not classified · Z-1560-2011: Staphylococcus aureus (not methicillin resistant) identified in companion tissue.

## Indications for use
CryoValve® SO Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

Source page: https://510kreport.com/device/K092021
Methodology: https://510kreport.com/methodology