# KRJ: Filter, Prebypass, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4280; FDA's rule: 510(k) exempt
- FDA decisions: 24
- Recalls: 0 (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)
- 1983: 2
- 1984: 2
- 1985: 1
- 1986: 1
- 1987: 1
- 1988: 4
- 1989: 1
- 1990: 1
- 1994: 1
- 1999: 2

## Most-cited predicates
- K850139: Cobe Cop Filter Cardiopulmonary Prebypass Filter (1985), cited by 1

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