# KIR: Cells, Animal And Human, Cultured

- Device class: 1; regulation: 21 CFR 864.2280; FDA's rule: 510(k) exempt
- FDA decisions: 170
- 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)
- 1985: 14
- 1986: 7
- 1987: 2
- 1990: 2
- 1992: 15
- 1993: 36
- 1994: 33
- 1995: 2
- 1996: 9
- 1997: 9

## Most-cited predicates
- K962306: Fresh Cells Multi-Well & Shell Vial Cultures (1996), cited by 1

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