# GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered

- Device class: 2; regulation: 21 CFR 880.6740; FDA's rule: 510(k) exempt
- FDA decisions: 87
- Recalls: 12 (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)
- 1990: 10
- 1991: 5
- 1992: 3
- 1993: 4
- 1994: 1
- 1995: 4
- 1996: 7
- 1997: 2
- 1999: 1
- 2004: 1

## Most-cited predicates
- K881252: Pleur-Evac (R) A6000 Adult/Pediatric Chest Drainage (1988), cited by 3
- K954726: Stryker Strykeflow Suction Irrigator (Modification) (1995), cited by 2
- K992126: Circon Surgiflex Wave Tsunami Suction-Irrigation System (1999), cited by 2
- K042454: Stryker Cassette Pump (2004), cited by 1
- K963648: Stryker Suction Regulator (1996), cited by 1

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