# IME: Pack, Hot Or Cold, Reusable

- Device class: 1; regulation: 21 CFR 890.5700; FDA's rule: 510(k) exempt
- FDA decisions: 27
- Recalls: 11 (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)
- 1979: 3
- 1980: 3
- 1981: 3
- 1982: 4
- 1983: 7
- 1986: 1
- 1988: 1
- 1991: 1
- 1992: 1
- 1993: 2

## Most-cited predicates

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