# DWA: Control, Pump Speed, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4380; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 256 days (middle half 146–256)
- Recalls: 8 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2007: 1
- 2008: 3
- 2009: 2
- 2010: 2
- 2011: 2
- 2013: 2
- 2019: 1
- 2020: 2
- 2023: 2
- 2024: 1

## Most-cited predicates
- K083340: Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console (2008), cited by 3
- K070286: Bio-Console, Model 560 (2007), cited by 3
- K936091: Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller (1994), cited by 3
- K011838: Centrifugal Pump (2002), cited by 3
- K102129: Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor (2010), cited by 2
- K950739: 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System (1995), cited by 2
- K061369: Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500 (2006), cited by 2
- K053630: Levitronix Centrimag Primary Console (2006), cited by 1
- K081221: Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console (2008), cited by 1
- K221491: Anivia SG1000 Pump Console (2023), cited by 1

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