# BSK: Cuff, Tracheal Tube, Inflatable

- Device class: 2; regulation: 21 CFR 868.5750; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 220 days (middle half 185–267)
- Recalls: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 1
- 2016: 4
- 2018: 2
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 1
- 2023: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K912723: Posey Cufflator (1991), cited by 6
- K092733: PYTON (2010), cited by 5
- K150893: IntelliCuff (2016), cited by 4
- K951046: Rusch Endotest Cuff Pressure Monitor (1995), cited by 3
- K833327: Respironics PR Valve (1983), cited by 3
- K102704: Easy Cuff (2011), cited by 3
- K081805: Cuffalert (2008), cited by 3
- K122721: AG Guffill (2013), cited by 2
- K142103: Cuff Pilot, Sure Seal (2015), cited by 2
- K885216: Attachable Lanz (Tentative) (1989), cited by 2

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