FDA product code · Cardiovascular
Heart Valve, More Than Minimally Manipulated Allograft
4 FDA decisions since 2008. 510(k) reviews decided 2021–2025 took a median of 93 days (half between 93 and 93). 1 recall names this code; it is not Class I. The most-cited predicate is K083106, named by 2 later devices.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OHA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in OHA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report