# DWB: Pump, Blood, Cardiopulmonary Bypass, Roller Type

- Device class: 2; regulation: 21 CFR 870.4370; FDA's rule: 510(k) required
- FDA decisions: 21
- Recalls: 2 (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: 1
- 1986: 2
- 1988: 2
- 1989: 1
- 1996: 3
- 1997: 2
- 1998: 2
- 2011: 1
- 2013: 1
- 2016: 1

## Most-cited predicates
- K960974: Cobe Century Perfusion Pump (1997), cited by 3
- K953901: Sarns 800  Roller Pump (1996), cited by 2
- K953904: Sarns 9000 Universal Roller Pump (1996), cited by 2
- K112587: Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color, (2011), cited by 2
- K971520: S3 Cyclic RPM Control (1997), cited by 2
- K955038: Stockert S3 Double Head Pump Module (1996), cited by 1

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