# HEP: Monitor, Blood-Flow, Ultrasonic

- Device class: 2; regulation: 21 CFR 884.2660; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 1991: 1
- 1992: 1
- 2003: 1
- 2010: 1

## Most-cited predicates
- K910462: Pocket Dop 3 (1991), cited by 2
- K101960: Sonotrax Series Ultrasonic Pocket Doppler (2010), cited by 1

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