# IKY: Mattress, Flotation Therapy, Non-Powered

- Device class: 1; regulation: 21 CFR 880.5150; FDA's rule: 510(k) exempt
- FDA decisions: 8
- Recalls: 2 (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)
- 1976: 1
- 1977: 2
- 1978: 1
- 1980: 2
- 1981: 1
- 1992: 1

## Most-cited predicates

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