Cleared Traditional

Saans (F4-01-00-000-000)

K251165 · Innaccel Technologies Private Limited · Anesthesiology
Jan 2026
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K251165 is an FDA 510(k) clearance for the Saans (F4-01-00-000-000), 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 review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K251165 FDA.gov
FDA Decision Cleared 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

Device Classification

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.

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