# HHM: Sound, Uterine

- Device class: 1; regulation: 21 CFR 884.4530; FDA's rule: 510(k) exempt
- FDA decisions: 10
- 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
- 1978: 1
- 1981: 1
- 1983: 1
- 1984: 1
- 1987: 1
- 1988: 2
- 1994: 1
- 2001: 1

## Most-cited predicates
- K870550: Teflon Uterine Sound (1987), cited by 1
- K760170: Intrauterine Sound, Plastic Disposable (1976), cited by 1

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