# QYW: Hospital Cardiac Telemetry

- Device class: 2; regulation: 21 CFR 870.1025; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 1995: 1
- 2014: 1

## Most-cited predicates
- K934913: Heartrac Ecg Monitoring System (1995), cited by 1
- K133973: Tempus Pro with Enhanced Features (2014), cited by 1

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