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.
2
Total
2
Cleared
263d
Avg days
2025
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Noninvasive Positive Airway Pressure System, Facility Use Devices (Product Code SGR)
2 devices
Cleared
Jan 06, 2026
Saans (F4-01-00-000-000)
Innaccel Technologies Private Limited
Anesthesiology
266d
Cleared
Nov 19, 2025
OptiPAP Junior Flexi Tube US (OPTIPAPFUS)
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
260d
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.