# IQA: System, Environmental Control, Powered

- Device class: 2; regulation: 21 CFR 890.3725; FDA's rule: 510(k) exempt
- FDA decisions: 24
- Recalls: 10 (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)
- 1987: 3
- 1988: 1
- 1989: 1
- 1990: 3
- 1991: 1
- 1992: 1
- 1993: 1
- 1994: 2
- 1995: 4
- 1996: 1

## Most-cited predicates

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