# QAV: High Flow/High Velocity Humidified Oxygen Delivery Device

- Device class: 2; regulation: 21 CFR 868.5454; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 242 days (middle half 232–253)
- 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)
- 2018: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- DEN170001: Precision Flow® HVNI (2018), cited by 2
- K221338: F&P Airvo 3 (2023), cited by 1

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