# DTP: Defoamer, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4230; FDA's rule: 510(k) required
- FDA decisions: 34
- 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)
- 1990: 3
- 1991: 3
- 1993: 1
- 1994: 1
- 1996: 1
- 1999: 2
- 2000: 1
- 2001: 1
- 2008: 1
- 2010: 1

## Most-cited predicates
- K870792: Thorastat Atr-XXXX (1987), cited by 1
- K933496: Maxima Filtered Hardshell Reservior (1993), cited by 1
- K911789: Minimax (TM) Hardshell Venous Res W/Inte Card Filt (1991), cited by 1
- K902856: Bard Filtered Cardiotomy Reservoir (1990), cited by 1
- K004046: Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir (2001), cited by 1

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