510(k) · Cleared
Recalled · Class II · 2024Cryopatch SG Pulmonary Hemi-Artery; Trunk; Branch
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 Aug 7, 2009 as substantially equivalent to K083106 (Cryolife, Inc., 2009) after a 65-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Aug 7, 2009
- Review
- 65 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083106 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK083106 Cryovalve SG Pulmonary Valve and ConduitCryolife, Inc. · 2009 · Recalled
- This deviceK091626 Cryopatch SG Pulmonary Hemi-Artery; Trunk; BranchCryolife, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK101866 Cryopatch SG Pulmonary Human Cardiac PatchCryolife, Inc. · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K101866Cryopatch SG Pulmonary Human Cardiac PatchCryolife, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083106 | Cryovalve SG Pulmonary Valve and Conduit | Cryolife, Inc. | 2009 | 1 |
| 0 (this device) | K091626 | Cryopatch SG Pulmonary Hemi-Artery; Trunk; Branch | Cryolife, Inc. | 2009 | — |
| +1 | K101866 | Cryopatch SG Pulmonary Human Cardiac Patch | Cryolife, Inc. | 2010 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083106 | Cryovalve SG Pulmonary Valve and ConduitSummary page 1…Cy~f- rc 038 2V0 H Conduit). Kennesaw.. GA K083 106 02r062009 Device Description: The CryoPatce- SG Pulmonary Hun an Cardiac Patch is derived from human pulmonary valv'e and art… | 2009 |
| * | — | MatrACELL Pulmonary Artery Patch Allograft Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101866 | Cryopatch SG Pulmonary Human Cardiac Patch | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2024 | Class II | Z-2532-2024 | Under Investigation by firm | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| Sep 6, 2018 | Class II | Z-0121-2019 | Labeling mix-ups | The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm. |
| Nov 21, 2016 | Class II | Z-1219-2019 | Release of Material/Component prior to receiving test results | The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2009, 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?
Indicated for repair or reconstruction of the right ventricular outflow tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091626 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091626: Cryopatch SG Pulmonary Hemi-Artery; Trunk; Branch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091626
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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