# NIK: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 4
- Recalls: 61 (6 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: 112
- 2018: 91
- 2019: 62
- 2020: 75
- 2021: 67
- 2022: 62
- 2023: 58
- 2024: 56
- 2025: 56
- 2026: 44

## Most-cited predicates
- P030054: ST Jude Medical Epic HF System (2004), cited by 4

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