# CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)

- Device class: 1; regulation: 21 CFR 868.5240; FDA's rule: 510(k) exempt
- FDA decisions: 184
- Recalls: 173 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1986: 5
- 1987: 5
- 1988: 3
- 1989: 4
- 1990: 5
- 1991: 10
- 1992: 1
- 1993: 47
- 1994: 29
- 1995: 11

## Most-cited predicates
- K852316: #3011 Pediatric Non-Conduct Anes Cir W/ Brea Bag (1985), cited by 1

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