510(k) · Cleared

Recalled · 2008

Human Heart Valve, Cryovalve SG

K033484510(k) TraditionalCleared Feb 7, 20081,556-day reviewClass URecalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cryolife, Inc. · OHA Heart Valve, More Than Minimally Manipulated Allograft

Cleared on Feb 7, 2008 after a 1,556-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 2 times.

Decided: Feb 7, 2008
Review: 1,556 days
Class: Class U
Product code: OHA
Recalls: 2
Predicates: 0

3 later devices descend from it, 1 citing it directly.

This deviceK033484 Human Heart Valve, Cryovalve SGCryolife, Inc. · 2008
Descendant · cites it directly · 2 of its ownK092021 Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. · 2010 · 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 3 of 3 · See all

K092021Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. · 2010 · cites it directly2descendants
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)	K033484	Human Heart Valve, Cryovalve SG	Cryolife, Inc.	2008	—
+1	K092021	Cryovalve SG Pulmonary Human Heart Valve (and Conduit)	Cryolife, Inc.	2010	5
+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
2010	2	0
2025	1	0

FIG. 1 — Lineage of K033484, 2008–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	—	Human Heart Valve Allograft - CryoValve Named without a submission number			—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K092021	Cryovalve SG Pulmonary Human Heart Valve (and Conduit)	Cryolife, Inc.	2010	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 26, 2008	Not classified	Z-1523-2008	Material/Component Contamination	Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
Mar 26, 2008	Not classified	Z-1524-2008	Material/Component Contamination	Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.

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 devices

OHA Heart Valve, More Than Minimally Manipulated Allograft: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OHA

1in 2025

2007high 1 (2008) · low 0 (2007)2026

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

2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OHA

8in 2025

2007high 15 (2023) · low 0 (2007)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/K033484 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033484: Human Heart Valve, Cryovalve SG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033484

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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