FDA Product Code BZR: Mixer, Breathing Gases, Anesthesia Inhalation
Leading manufacturers include Parker Hannifin Corporation and Fisher &Paykel Healthcare , Ltd..
55
Total
55
Cleared
142d
Avg days
1976
Since
Declining activity -
2 submissions in the last 2 years
vs 4 in the prior period
Consistent review times:
163d avg (recent)
FDA 510(k) Cleared Mixer, Breathing Gases, Anesthesia Inhalation Devices (Product Code BZR)
55 devices
Cleared
Jul 14, 2025
F&P Optiflow Air/Oxygen Flow Source
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
206d
Cleared
Sep 19, 2024
Midas Flowmeter
Parker Hannifin Corporation
Anesthesiology
119d
About Product Code BZR - Regulatory Context
510(k) Submission Activity
55 total 510(k) submissions under product code BZR since 1976, with 55 receiving FDA clearance (average review time: 142 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
FDA review times for BZR submissions have been consistent, averaging 163 days recently vs 142 days historically.
BZR devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →