SGR — Noninvasive Positive Airway Pressure System, Facility Use Class II

FDA Device Classification

Classification Details

Product Code: SGR
Device Class: Class II
Regulation Number: 868.5895
Submission Type
Review Panel: AN
Medical Specialty: Anesthesiology
Implant: No

Definition

To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K251165	innaccel technologies private limited	Saans (F4-01-00-000-000)	January 6, 2026
K250651	fisher and paykel healthcare	OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTI	November 19, 2025