# CAE: Airway, Oropharyngeal, Anesthesiology

- Device class: 1; regulation: 21 CFR 868.5110; FDA's rule: 510(k) exempt
- FDA decisions: 57
- Recalls: 65 (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)
- 1989: 5
- 1991: 2
- 1992: 1
- 1994: 2
- 1995: 1
- 1996: 2
- 1997: 1
- 2003: 1
- 2004: 2
- 2014: 1

## Most-cited predicates
- K021634: King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (2003), cited by 2
- K830767: Williams Airway Intubator (1983), cited by 1
- K904834: Intavent Laryngeal Mask (1991), cited by 1
- K130304: Lma Family of Airways (2014), cited by 1

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