# HEL: Monitor, Heart Rate, Fetal, Ultrasonic

- Device class: 2; regulation: 21 CFR 884.2660; FDA's rule: 510(k) required
- FDA decisions: 7
- 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)
- 1978: 1
- 1994: 1
- 1995: 1
- 1997: 1
- 1998: 1
- 2001: 2

## Most-cited predicates
- K982651: Corometrics Model 5700 and 2264 Watertight Transducer (1998), cited by 3

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