510(k) · Cleared
Recalled · Class II · 2024Cryovalve SG Pulmonary Human Heart 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 May 25, 2010 as substantially equivalent to K033484 (Cryolife, Inc., 2008) and 1 other predicate after a 323-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- May 25, 2010
- Review
- 323 days
- Class
- Class U
- Product code
- OHA
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033484 (2008). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK033484 Human Heart Valve, Cryovalve SGCryolife, Inc. · 2008 · Recalled
- This deviceK092021 Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK252059 CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve…Artivion, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK101866 Cryopatch SG Pulmonary Human Cardiac PatchCryolife, Inc. · 2010 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033484 | Human Heart Valve, Cryovalve SG | Cryolife, Inc. | 2008 | 2 |
| 0 (this device) | K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit) | Cryolife, Inc. | 2010 | — |
| +1 | K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit… | Artivion, Inc. | 2025 | — |
| +1 | K101866 | Cryopatch SG Pulmonary Human Cardiac Patch | Cryolife, Inc. | 2010 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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? (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 |
|---|---|---|---|
| * | K033484 | Human Heart Valve, Cryovalve SGSummary page 1…Clearance Date Code CryoValve® SGO Pulmonay Huma Heart Cryol-ife, Inc. K033484 - 02/07/2008OH Valveo(and Comndui at) Kennesaw, GA K083 106 - 02/06/2009OA Devi… | 2008 |
| * | K083106 | Cryovalve SG Pulmonary Valve and ConduitSummary page 1…art Cryol-ife, Inc. K033484 - 02/07/2008OH Valveo(and Comndui at) Kennesaw, GA K083 106 - 02/06/2009OA Device Description: The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve (CryoValve SG) is a human hear… | 2009 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| May 28, 2024 | Class II | Z-2531-2024 | Under Investigation by firm | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| Mar 6, 2024 | Class II | Z-1545-2024 | Under Investigation by firm | The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. |
| Nov 10, 2020 | Class II | Z-0652-2021 | 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-2271-2018 | 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. |
| Feb 17, 2011 | Not classified | Z-1560-2011 | Other | Staphylococcus aureus (not methicillin resistant) identified in companion tissue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K252059 (Artivion, Inc., 2025) has gone furthest, with 0 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. 2010, 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® 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092021
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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