# KMH: Sterilizer, Dry Heat

- Device class: 2; regulation: 21 CFR 880.6870; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 0 (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)
- 1977: 1
- 1985: 1
- 1987: 2
- 1988: 2
- 1991: 1
- 1992: 1
- 2005: 1
- 2011: 1

## Most-cited predicates
- K880322: Dentronix DDS 5000 Dry Heat Sterilization System (1988), cited by 1
- K771070: Dry Heat Sterilizer (1977), cited by 1

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