# KAC: Tube, Laryngectomy

- Device class: 1; regulation: 21 CFR 874.4420; FDA's rule: 510(k) exempt
- FDA decisions: 4
- Recalls: 1 (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)
- 1981: 1
- 1982: 1
- 1988: 1
- 1990: 1

## Most-cited predicates
- K821993: Shiley Laryngectomy Tube (1982), cited by 2

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