Home / 510(k) Clearances / K251165

510(k) K251165

Saans (F4-01-00-000-000) by Innaccel Technologies Private Limited — Product Code SGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2026
Date Received
April 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Noninvasive Positive Airway Pressure System, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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

Other clearances for product code SGR

  • K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTI (November 19, 2025)