510(k) · Cleared
Recalled · Class II · 2026Cryopatch SG Pulmonary Human Cardiac Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryolife, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Jul 23, 2010 as substantially equivalent to K091626 (Cryolife, Inc., 2009) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 2009. It has been recalled 5 times.
- Decided
- Jul 23, 2010
- Review
- 21 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 2 generations to K083106 (2009). 4 ancestors in all, the oldest K033484 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K083106 | Cryovalve SG Pulmonary Valve and Conduit | Cryolife, Inc. | 2009 | 1 |
| −1 | K091626 | Cryopatch SG Pulmonary Hemi-Artery; Trunk; Branch | Cryolife, Inc. | 2009 | 3 |
| 0 (this device) | K101866 | Cryopatch SG Pulmonary Human Cardiac Patch | Cryolife, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXZ device
- #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091626 | Cryopatch SG Pulmonary Hemi-Artery; Trunk; BranchSummary page 1…Clearance Date Code CryoPatch® SG CryoLife, Inc. Pulmonary Human Kennesaw, GA K091626 w.08/07f2009 DYZ Cardiac Patch CryoValve" SGO038… | 2009 |
| Kept off the family tree | K083140 | FDA’s K083140 is Compex Sport Plus 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…lve" SGO038 0/720 Pulmonary Human Heart CryoLife, Inc. K0831404 - 02/07/2008 H Valve (and Conduit). Kennesaw, GA K09202… | 2009 |
| * | K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit) 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)”. | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2026 | Not classified | Z-0325-2027 | Nonconforming Material/Component | 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 limitations of long-term in vivo data… |
| Nov 10, 2020 | Class II | Z-0653-2021 | Material/Component Contamination | 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 processing allografts subjected to the recall. |
| May 14, 2018 | Class II | Z-2272-2018 | Under Investigation by firm | 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 | Other | 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 | Other | Staphylococcus aureus (not methicillin resistant) identified in companion tissue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 11 months on median.
- 4 of the 4 ancestors have a recall of any class.
How does its category compare?
All DXZ devicesDXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DXZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXZ
106in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXZ
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DXZ
119in 2025
MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 50 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 109 |
| 2010 | 3 | 91 | 2 | 81 |
| 2011 | 2 | — | 2 | 47 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 1 | — | 2 | 69 |
| 2014 | 3 | 106 | 0 | 93 |
| 2015 | 2 | — | 0 | 171 |
| 2016 | 2 | — | 0 | 66 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 1 | 44 |
| 2019 | 0 | — | 0 | 55 |
| 2020 | 1 | — | 1 | 121 |
| 2021 | 0 | — | 0 | 80 |
| 2022 | 0 | — | 0 | 77 |
| 2023 | 0 | — | 2 | 40 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 1 | — | 2 (2) | 119 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
CryoPatch SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101866: Cryopatch SG Pulmonary Human Cardiac Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101866
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026