# DTW: Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4340; FDA's rule: 510(k) exempt
- FDA decisions: 17
- Recalls: 15 (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)
- 1985: 1
- 1986: 1
- 1987: 1
- 1990: 2
- 1992: 1
- 1993: 2
- 1996: 1
- 1999: 1
- 2004: 1
- 2015: 1

## Most-cited predicates
- K955152: Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., Timer (1996), cited by 1
- K041558: Stockertir Purge Control (Apc) System (2004), cited by 1

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