# CCT: Applicator (Laryngo-Tracheal), Topical Anesthesia

- Device class: 2; regulation: 21 CFR 868.5170; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 274 days (middle half 274–274)
- Recalls: 4 (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)
- 1976: 2
- 1981: 1
- 1990: 1
- 2000: 1
- 2007: 1
- 2011: 1
- 2016: 1
- 2018: 1
- 2024: 1

## Most-cited predicates
- K002255: Laryngo-Tracheal Mucosal Atomization Device (Madgic) (2000), cited by 4
- K070596: Topical Applicator (2007), cited by 1
- K153470: MADgic Laryngo-Tracheal Mucosal Atomization Device (2016), cited by 1

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