# DYE: Replacement Heart-Valve

- Device class: 3; regulation: 21 CFR 870.3925; FDA's rule: PMA required
- FDA decisions: 8
- Recalls: 2 (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)
- 2017: 34
- 2018: 27
- 2019: 16
- 2020: 13
- 2021: 7
- 2022: 8
- 2023: 11
- 2024: 7
- 2025: 13
- 2026: 7

## Most-cited predicates

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