510(k) · Cleared
ClearedCryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artivion, Inc. · OHA Heart Valve, More Than Minimally Manipulated Allograft
Cleared on Oct 2, 2025 as substantially equivalent to K092021 (Cryolife, Inc., 2010) after a 93-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Oct 2, 2025
- Review
- 93 days
- Class
- Class U
- Product code
- OHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033484 (2008). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK033484 Human Heart Valve, Cryovalve SGCryolife, Inc. · 2008 · Recalled
- 1 generation backK092021 Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. · 2010 · Recalled
- This deviceK252059 CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve…Artivion, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033484 | Human Heart Valve, Cryovalve SG | Cryolife, Inc. | 2008 | 2 |
| −1 | K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit) | Cryolife, Inc. | 2010 | 5 |
| 0 (this device) | K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit… | Artivion, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Summary page 5…Clearance Date Code CryoValve® SG Pulmonary Valve CryoLife, Inc. CryoValve® SG Pulmonary Valve 1655 Roberts Blvd., NW K092021 – May 25, 2010 OHA and Conduit Kennesaw, GA 30144 Device Description: The CryoValve SG Pulmonary H… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 15.4 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K092021.
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. 2025, 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 as stated in the FDA summary.
https://510kreport.com/device/K252059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252059: CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252059
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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