FDA product code OHA: Heart Valve, More Than Minimally Manipulated Allograft
OHA is the FDA product code for heart valve, more than minimally manipulated allograft. It is a Unclassified device, reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under OHA, 1 in the last five years, from 2 different applicants. The average 510(k) review took 520 days (median 216); 93 days on average over the last three years. FDA has posted 4 recalls for OHA devices, 2 initiated in the last five years.
Definition
For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.
Classification
| Field | Value |
|---|---|
| Device name | Heart Valve, More Than Minimally Manipulated Allograft |
| Device class | Unclassified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OHA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 93 |
Compare with all 510(k) review times · Search every OHA clearance
Top OHA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cryolife, Inc. | 3 | 2010-05-25 |
| Artivion, Inc. | 1 | 2025-10-02 |
Most recent OHA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252059 | Artivion, Inc. | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | 2025-10-02 | 93 |
| K092021 | Cryolife, Inc. | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | 2010-05-25 | 323 |
| K083106 | Cryolife, Inc. | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | 2009-02-06 | 109 |
| K033484 | Cryolife, Inc. | HUMAN HEART VALVE, CRYOVALVE SG | 2008-02-07 | 1556 |
Recalls for OHA devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-05-28.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code OHA?
OHA is the FDA product code for heart valve, more than minimally manipulated allograft. It is a Unclassified device, reviewed by the Cardiovascular panel.
What device class is OHA?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code OHA?
Across 4 cleared submissions the average was 520 days from receipt to decision (median 216).
Which companies have the most OHA clearances?
Cryolife, Inc. (3); Artivion, Inc. (1).
Have OHA devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-05-28.
Next steps
- Run an FDA pathway report with predicate devices for product code OHA
- Run a recall and safety report across every OHA manufacturer
- Watch product code OHA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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