Cleared Traditional

NASAL-AIR CRITICAL CARE (K031896) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031896 · Innomed Technologies · Anesthesiology device
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Jan 2004
Decision
209d
Days
Class 2
Risk

K031896 is an FDA 510(k) clearance for the NASAL-AIR CRITICAL CARE. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Innomed Technologies (Greensburg, US). The FDA issued a Cleared decision on January 14, 2004 after a review of 209 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 Innomed Technologies devices

Submission Details

510(k) Number K031896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2003
Decision Date January 14, 2004
Days to Decision 209 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 140d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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.

Regulatory Peers - MNS Ventilator, Continuous, Non-life-supporting

All 36
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K031896.
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K020777 · Respironics, Inc. · Mar 2002
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
K012323 · Respironics, Inc. · Dec 2001