Saans (F4-01-00-000-000)
FDA 510(k) K251165 · Innaccel Technologies Private Limited
510(k) numberK251165
Submission
- Device name
- Saans (F4-01-00-000-000)
- Applicant
- Innaccel Technologies Private Limited
Bengaluru, IN - Received
- April 15, 2025
- Decision date
- January 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SGR – Noninvasive Positive Airway Pressure System, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.
Other 510(k)s with product code SGR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…SGR · Traditional | Fisher & Paykel Healthcare, Ltd. | 11/19/2025SE |
Questions and answers
When was Saans (F4-01-00-000-000) cleared by the FDA?
Saans (F4-01-00-000-000) (K251165) received a 510(k) decision of Substantially Equivalent on January 6, 2026, 266 days after the submission was received.
What is the product code of K251165?
The FDA product code is SGR – Noninvasive Positive Airway Pressure System, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.