# DWD: Suction Control, Intracardiac, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4430; FDA's rule: 510(k) exempt
- FDA decisions: 15
- 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)
- 1976: 1
- 1983: 2
- 1985: 1
- 1986: 3
- 1987: 1
- 1990: 1
- 1991: 1
- 1992: 3
- 1993: 1
- 2000: 1

## Most-cited predicates
- K861428: Suction Control Valve (Nonadjustable) Cat.RLV-2100 (1986), cited by 1
- K920077: Nikkiso NK Pump (1993), cited by 1
- K760894: Vacuum Relief Valve (1976), cited by 1

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