# OHA: Heart Valve, More Than Minimally Manipulated Allograft

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 93 days (middle half 93–93)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2008: 1
- 2009: 1
- 2010: 1
- 2025: 1

## Most-cited predicates
- K083106: Cryovalve SG Pulmonary Valve and Conduit (2009), cited by 2
- K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit) (2010), cited by 2
- K033484: Human Heart Valve, Cryovalve SG (2008), cited by 1

Source page: https://510kreport.com/product-code/OHA
Data by year (CSV): https://510kreport.com/product-code/OHA.csv