# LWR: Heart-Valve, Non-Allograft Tissue

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 12
- 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: 54
- 2018: 64
- 2019: 50
- 2020: 32
- 2021: 18
- 2022: 37
- 2023: 26
- 2024: 27
- 2025: 27
- 2026: 19

## Most-cited predicates

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