# HFM: Monitor, Uterine Contraction, External (For Use In Clinic)

- Device class: 2; regulation: 21 CFR 884.2720; FDA's rule: 510(k) required
- FDA decisions: 24
- 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)
- 1991: 3
- 1993: 1
- 1994: 1
- 1995: 2
- 1996: 1
- 2000: 2
- 2002: 1
- 2004: 1
- 2006: 1
- 2014: 1

## Most-cited predicates
- K013477: Toco Lite, Model TD-01 (2002), cited by 3
- K992811: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring (2000), cited by 2

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