FDA Product Code QAV: High Flow/high Velocity Humidified Oxygen Delivery Device
Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification.
Leading manufacturers include Vapotherm, Inc. and Fisher & Paykel Healthcare.
3
Total
2
Cleared
315d
Avg days
2018
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared High Flow/high Velocity Humidified Oxygen Delivery Device Devices (Product Code QAV)
3 devices
Cleared
Jan 27, 2023
F&P Airvo 3
Fisher & Paykel Healthcare
Anesthesiology
263d
Cleared
Dec 13, 2022
HVT 2.0
Vapotherm, Inc.
Anesthesiology
221d
About Product Code QAV - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QAV since 2018, with 2 receiving FDA clearance (average review time: 315 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QAV devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →