# DTQ: Console, Heart-Lung Machine, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4220; FDA's rule: 510(k) required
- FDA decisions: 52
- 510(k) review time 2021–2025: median 219 days (middle half 76–292)
- Recalls: 194 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2009: 3
- 2010: 1
- 2011: 2
- 2014: 2
- 2015: 2
- 2017: 2
- 2018: 1
- 2019: 1
- 2021: 2
- 2023: 3

## Most-cited predicates
- K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch (2003), cited by 6
- K871131: Sarns 9000 Heart-Lung Console (1987), cited by 4
- K090006: Lifebridge B2T, Model 7001 (2009), cited by 3
- K071318: Modification to: Stockert S5 System (2007), cited by 3
- K060053: Stockert S5 System (2006), cited by 3
- K915183: Sarns 8000 Modular Perfusion System (1992), cited by 3
- K153376: Advanced Perfusion System 1 (2015), cited by 2
- K052555: Medtronic Performer TM CPB, Model R51, PCPB (2006), cited by 2
- K982014: Stockert Compact System (1998), cited by 2
- K950990: Stockert S3 Roller Pump Module Stockert S3 Console (1996), cited by 2

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