# INX: Bed, Air Fluidized

- Device class: 2; regulation: 21 CFR 890.5160; FDA's rule: 510(k) exempt
- FDA decisions: 28
- Recalls: 9 (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)
- 1988: 5
- 1989: 1
- 1990: 1
- 1991: 3
- 1992: 1
- 1993: 3
- 1994: 2
- 1995: 2
- 1997: 1
- 1998: 1

## Most-cited predicates
- K880340: Modified Air Fluidized Bed, Kinair (1988), cited by 1
- K942184: Clinitron at Home Air Fluided Therapy (1995), cited by 1
- K943385: Clinitron Elexis (1995), cited by 1
- K881917: Fluidair (1988), cited by 1

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