# DTY: Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4410; FDA's rule: 510(k) required
- FDA decisions: 8
- Recalls: 2 (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: 1
- 1984: 1
- 1987: 1
- 1990: 2
- 1996: 1
- 1997: 1
- 2010: 1

## Most-cited predicates
- K902654: Cdi (TM) System 100 Monitoring System (1990), cited by 3
- K963698: CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4 (1997), cited by 2
- K954501: Biotrend Oxygen Saturation & Hematocrit System (1996), cited by 1
- K093650: Biotrend Oxygen Saturation and Hematocrit System (2010), cited by 1

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