# QYE: Reduced Ejection Fraction Machine Learning-Based Notification Software

- Device class: 2; regulation: 21 CFR 870.2380; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 174 days (middle half 146–180)
- 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)
- 2023: 1
- 2024: 1
- 2025: 3
- 2026: 1

## Most-cited predicates
- K232699: Low Ejection Fraction AI-ECG Algorithm (2023), cited by 4
- K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (2025), cited by 3

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