DeviceClearance

Product code SGR— Anesthesiology

OptiPAP Junior Flexi Tube US (OPTIPAPFUS) +10 more

Classification name
Noninvasive Positive Airway Pressure System, Facility Use
Device class
Class 2
Regulation
21 CFR 868.5895
Advisory panel
Anesthesiology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code SGR under 21 CFR 868.5895, via openFDA

Market context for product code SGR

FDA has cleared 2 devices under product code SGR between 2025 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SGR

Recent clearances under product code SGR

Data sourced from openFDA. This site is unofficial and independent of the FDA.