# DWC: Controller, Temperature, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4250; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 257 days (middle half 256–257)
- Recalls: 21 (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)
- 2002: 1
- 2003: 1
- 2006: 1
- 2007: 1
- 2010: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2020: 1
- 2022: 2

## Most-cited predicates
- K031544: Heater Cooler Unit, Model Hcu 30 (2003), cited by 3
- K052601: Stockert Heater-Cooler System 3T (2006), cited by 3
- K883603: Sarns Temp. Control and Monitor System (TCM II) (1988), cited by 2
- K001520: Alpha Omega Dual Cooler-Heater (2000), cited by 2
- K191402: Heater-Cooler System 3T (2020), cited by 1

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