K251165 is an FDA 510(k) clearance for the Saans (F4-01-00-000-000). This device is classified as a Noninvasive Positive Airway Pressure System, Facility Use (Class II - Special Controls, product code SGR).
Submitted by Innaccel Technologies Private Limited (Bengaluru, IN). The FDA issued a Cleared decision on January 6, 2026, 266 days after receiving the submission on April 15, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895. To Mechanically Assist Patient Breathing By Delivering A Predetermined Percentage Of Oxygen In The Breathing Gas Through Noninvasive Continuous Positive Airway Pressure..
| 510(k) Number | K251165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2025 |
| Decision Date | January 06, 2026 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | SGR - Noninvasive Positive Airway Pressure System, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |
| Definition | To Mechanically Assist Patient Breathing By Delivering A Predetermined Percentage Of Oxygen In The Breathing Gas Through Noninvasive Continuous Positive Airway Pressure. |