Cleared Traditional

K251165 - Saans (F4-01-00-000-000)

K251165 is an FDA 510(k) clearance for Saans (F4-01-00-000-000), manufactured by Innaccel Technologies Private Limited. The device is a Class 2 Anesthesiology device with product code SGR cleared through the Traditional 510(k) pathway after a 266-day FDA review.

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

K251165 is an FDA 510(k) clearance for the Saans (F4-01-00-000-000). Classified as Noninvasive Positive Airway Pressure System, Facility Use (product code SGR), Class II - Special Controls.

Submitted by Innaccel Technologies Private Limited (Bengaluru, IN). The FDA issued a Cleared decision on January 6, 2026 after a review of 266 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Innaccel Technologies Private Limited devices

FDA 510(k) Submission Details - K251165

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 140d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SGR Device Classification - Class 2, Special Controls

Product Code SGR Noninvasive Positive Airway Pressure System, Facility Use
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.