# NKM: Mitral Valve Repair Devices

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 4 (1 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: 4
- 2018: 3
- 2019: 9
- 2020: 1
- 2021: 5
- 2022: 12
- 2023: 20
- 2024: 15
- 2025: 16
- 2026: 11

## Most-cited predicates

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