# IRQ: Unit, Heating, Powered

- Device class: 1; regulation: 21 CFR 890.5950; FDA's rule: 510(k) exempt
- FDA decisions: 7
- Recalls: 1 (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: 1
- 1983: 1
- 1986: 1
- 1988: 1
- 1993: 1
- 1995: 1
- 2005: 1

## Most-cited predicates

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