510(k) · Cleared
Recalled · 2011Cryovalve SG Pulmonary Valve and Conduit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryolife, Inc. · OHA Heart Valve, More Than Minimally Manipulated Allograft
Cleared on Feb 6, 2009 after a 109-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 6, 2009
- Review
- 109 days
- Class
- Class U
- Product code
- OHA
- Recalls
- 1
- Predicates
- 1
4 later devices descend from it, 2 citing it directly.
- This deviceK083106 Cryovalve SG Pulmonary Valve and ConduitCryolife, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK092021 Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. · 2010 · Recalled
- Descendant · cites it directly · 1 of its ownK091626 Cryopatch SG Pulmonary Hemi-Artery; Trunk; BranchCryolife, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK252059 CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve…Artivion, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK101866 Cryopatch SG Pulmonary Human Cardiac PatchCryolife, Inc. · 2010 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K092021Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. · 2010 · cites it directly2descendants
- K091626Cryopatch SG Pulmonary Hemi-Artery; Trunk; BranchCryolife, Inc. · 2009 · cites it directly1descendant
- K252059CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)Artivion, Inc. · 2025 · 2 generations on0descendants
- K101866Cryopatch SG Pulmonary Human Cardiac PatchCryolife, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083106 | Cryovalve SG Pulmonary Valve and Conduit | Cryolife, Inc. | 2009 | — |
| +1 | K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit) | Cryolife, Inc. | 2010 | 5 |
| +1 | K091626 | Cryopatch SG Pulmonary Hemi-Artery; Trunk; Branch | Cryolife, Inc. | 2009 | 3 |
| +2 | K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit… | Artivion, Inc. | 2025 | — |
| +2 | K101866 | Cryopatch SG Pulmonary Human Cardiac Patch | Cryolife, Inc. | 2010 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2025 | 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 OHA? 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 OHA device
- #1 K252059 CryoValve SG Pulmonary Valve (SGPV10)…score 10.4 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| Kept off the family tree | K033484 | FDA’s K033484 is Human Heart Valve, Cryovalve SG Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2011 | Not classified | Z-1219-2011 | Other | A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092021 (Cryolife, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OHA devicesOHA Heart Valve, More Than Minimally Manipulated Allograft: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OHA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHA
Too few OHA 510(k)s in any year since 2007 to give a median.
Recalls per year · OHA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHA
8in 2025
MAUDE reports naming product code OHA, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 1 | 12 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CryoValve® SG 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K083106 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083106: Cryovalve SG Pulmonary Valve and Conduit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083106
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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