# DTX: Gas Control Unit, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4300; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 60 days (middle half 60–60)
- 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)
- 1979: 2
- 1982: 1
- 1986: 1
- 1997: 1
- 2003: 1
- 2010: 1
- 2018: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K965214: Coeur Front Load Injector Retrofit Kit (C859-0002) (1997), cited by 2
- K023745: Sechrist Air/Oxygen Mixer, Model 3500 CP-G (2003), cited by 1
- K181942: Quantum Ventilation Module (2018), cited by 1
- K863902: Modified Sarns Membrane Oxygenator (1986), cited by 1
- K101046: Stockert S5 System and Gas Blender and Sorin C5 System (2010), cited by 1
- K202733: Quantum Ventilation Module (2020), cited by 1

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