# OQU: Airway Monitoring System

- Device class: 2; regulation: 21 CFR 868.5730; FDA's rule: 510(k) required
- FDA decisions: 3
- Recalls: 1 (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)
- 2010: 1
- 2016: 1
- 2020: 1

## Most-cited predicates
- K092611: Sonarmed Airway Monitoring System, Model 0901 (2010), cited by 1
- K143042: SonarMed AirWave, Airway Monitoring System (2016), cited by 1

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