# K101866: Cryopatch SG Pulmonary Human Cardiac Patch

- Pathway: 510(k) (Special)
- Applicant: Cryolife, Inc.
- Decided: Jul 23, 2010 after 21 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- 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: 2 generations back to K083106 (2009). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091626: Cryopatch SG Pulmonary Hemi-Artery; Trunk;  Branch, Cryolife, Inc. (2009) Summary page 1.
- K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit), Cryolife, Inc. (2010). Our reading of the summary gave K092020, FDA’s number for Aadva ZR Coloring Liquid (GC America, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CryoValve® SGO038 Pulmonary Human Heart Valve (and Conduit)”.

## Cited in the summary but kept off the family tree
- K083140: Compex Sport Plus, Chattanooga Group (2009). Our reading of the summary gave K083140, FDA’s number for Compex Sport Plus (Chattanooga Group). Its FDA name has none of the distinctive words the summary uses for the device it names, “CryoValve® SGO038 Pulmonary Human Heart Valve (and Conduit)”. Kept off the family tree. Summary page 1.

## Recalls of this device
- Sep 18, 2026 · Not classified · Z-0325-2027: A cryopreserved pulmonary human cardiac patch, taken from a 64-year-old human donor, was outside the cardiac tissue donor age specification of newborn to 60 years. The patch was implanted, and due to 
- Nov 10, 2020 · Class II · Z-0653-2021: 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-2272-2018: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
- Nov 22, 2013 · Class II · Z-0809-2014: Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
- Feb 17, 2011 · Not classified · Z-1561-2011: Staphylococcus aureus (not methicillin resistant) identified in companion tissue.

## Indications for use
CryoPatch SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract

Source page: https://510kreport.com/device/K101866
Methodology: https://510kreport.com/methodology