510(k) K251165
K251165 is an FDA 510(k) premarket notification submitted by Innaccel Technologies Private Limited for the device "Saans (F4-01-00-000-000)". The FDA issued a decision of Substantially Equivalent on January 6, 2026. The device falls under product code SGR (Noninvasive Positive Airway Pressure System, Facility Use), a Class II device regulated under 21 CFR 868.5895.
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.