# KCY: Tourniquet, Pneumatic

- Device class: 1; regulation: 21 CFR 878.5910; FDA's rule: 510(k) exempt
- FDA decisions: 34
- 510(k) review time 2021–2025: median 233 days (middle half 233–233)
- Recalls: 93 (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)
- 1994: 2
- 1995: 6
- 1996: 1
- 2001: 1
- 2005: 1
- 2007: 1
- 2011: 1
- 2013: 1
- 2017: 1
- 2021: 1

## Most-cited predicates
- K012632: Tourniquet Cuff; Pneumatic Tourniquet (2001), cited by 1
- K050411: Zimmer a.T.S. 3000 Automatic Tourniquet System (2005), cited by 1
- K840206: Pressure Sentry Tourniquet (1984), cited by 1
- K123553: Zimmer a.T.S. 4000TS Automatic Tourniquet System (2013), cited by 1
- K890014: Disposable Color-Cuffs (1989), cited by 1
- K112874: EZ Vein Inflatable Tourniquet (2011), cited by 1
- K953953: Deroyal Industries, Inc. Pneumatic Tourniquet Cuff (1995), cited by 1

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