# DXS: Gauge, Pressure, Coronary, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4310; FDA's rule: 510(k) required
- FDA decisions: 13
- Recalls: 3 (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)
- 1982: 2
- 1983: 1
- 1984: 1
- 1985: 1
- 1986: 1
- 1987: 1
- 1990: 1
- 1991: 1
- 1994: 1
- 2011: 1

## Most-cited predicates
- K862836: Stockert-Shiley Caps and Caps Dual Pressure Module (1986), cited by 1
- K852232: Pressure Display Box #60000/Tubing Set #61000 (1985), cited by 1

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