# QRS: Device For Sleep Apnea Testing Based On Mandibular Movement

- Device class: 2; regulation: 21 CFR 868.2376; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 153 days (middle half 150–155)
- 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)
- 2022: 2
- 2025: 1

## Most-cited predicates
- K222262: Sunrise (2022), cited by 1
- DEN210015: Sunrise Sleep Disorder Diagnostic Aid (2022), cited by 1

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