# KRI: Accessory Equipment, Cardiopulmonary Bypass

- Device class: 1; regulation: 21 CFR 870.4200; FDA's rule: 510(k) exempt
- FDA decisions: 42
- Recalls: 5 (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)
- 1984: 3
- 1985: 3
- 1986: 5
- 1987: 1
- 1988: 2
- 1989: 3
- 1992: 1
- 1993: 2
- 1999: 2
- 2002: 1

## Most-cited predicates
- K810079: Sarns Integrated Cardioplegia Deliv. Sys (1981), cited by 1
- K813271: Temperature Probes (1981), cited by 1

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