# DWE: Tubing, Pump, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4390; FDA's rule: 510(k) required
- FDA decisions: 21
- 510(k) review time 2021–2025: median 265 days (middle half 265–265)
- Recalls: 13 (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)
- 1998: 1
- 1999: 1
- 2000: 1
- 2002: 2
- 2005: 1
- 2008: 1
- 2009: 1
- 2014: 1
- 2015: 1
- 2024: 1

## Most-cited predicates
- K080592: HLM Tubing Set with Bioline Coating (2008), cited by 4
- K013578: Pump Tubing (2002), cited by 3
- K053025: Jostra HLM Tubing Set (2005), cited by 3
- K800178: Extracorp.'S Intersept Cus. Tubing PK. (1980), cited by 3
- K810924: Medrad High Pressure Conecting Tube (1981), cited by 2
- K803277: Tygon Tubing (1981), cited by 2
- K841959: Cardio Metric Custom Perfusion Tubing (1984), cited by 1
- K902845: Gentle Header (1990), cited by 1
- K981613: Cobe Smarxt Tubing and Connectors (1998), cited by 1
- K092486: Vortex Medical Angiovac Cardiopulmonary Bypass Circuit (2009), cited by 1

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