# GAZ: Tubing, Noninvasive

- Device class: 2; regulation: 21 CFR 880.6740; FDA's rule: 510(k) exempt
- FDA decisions: 27
- Recalls: 13 (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)
- 1980: 2
- 1982: 1
- 1983: 4
- 1984: 2
- 1986: 1
- 1987: 1
- 1988: 2
- 1991: 4
- 1993: 1
- 1995: 2

## Most-cited predicates
- K911865: Nortec Connecting Tube Set (1991), cited by 1
- K930512: Suction/Irrigation Y Tubing Set W/Trumpet Valves (1993), cited by 1

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