Cleared Traditional

MODIFICATION TO NASAL-AIRE (K022465) - FDA 510(k) Clearance

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

K022465 · Innomed Technologies · Anesthesiology device
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Mar 2003
Decision
238d
Days
Class 2
Risk

K022465 is an FDA 510(k) clearance for the MODIFICATION TO NASAL-AIRE. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Innomed Technologies (Greensburg, US). The FDA issued a Cleared decision on March 21, 2003 after a review of 238 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 K022465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2002
Decision Date March 21, 2003
Days to Decision 238 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 140d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K022465.
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MIRAGE ACTIVA MASK
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TWLIGHT, MODEL ISP 9600
K022642 · Invacare Corp. · Feb 2003
MIRAGE FULL FACE MASK SERIES 2
K023244 · Resmed, Ltd. · Nov 2002
MIRAGE FULL FACE MASK SERIES 2
K023284 · Resmed, Ltd. · Nov 2002