FDA Product Code SGR: Noninvasive Positive Airway Pressure System, Facility Use
To Mechanically Assist Patient Breathing By Delivering A Predetermined Percentage Of Oxygen In The Breathing Gas Through Noninvasive Continuous Positive Airway Pressure.
Leading manufacturers include Fisher &Paykel Healthcare , Ltd. and Innaccel Technologies Private Limited.
FDA 510(k) Cleared Noninvasive Positive Airway Pressure System, Facility Use Devices (Product Code SGR)
About Product Code SGR - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SGR since 2025, with 2 receiving FDA clearance (average review time: 263 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SGR devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →