# QZW: Over-The-Counter Device To Assess Risk Of Sleep Apnea

- Device class: 2; regulation: 21 CFR 868.2378; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 162 days (middle half 162–162)
- 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)
- 2024: 2
- 2026: 1

## Most-cited predicates
- DEN230041: Sleep Apnea Feature (2024), cited by 2
- K240929: Sleep Apnea Notification Feature (SANF) (2024), cited by 1

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