Cleared Traditional

K023673 - AIRLIFE DEMAND NASAL CANNULA (FDA 510(k) Clearance)

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

K023673 · Allegiance Healthcare Corp. · Anesthesiology device
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May 2003
Decision
182d
Days
Class 2
Risk

K023673 is an FDA 510(k) clearance for the AIRLIFE DEMAND NASAL CANNULA. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 182 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 Allegiance Healthcare Corp. devices

Submission Details

510(k) Number K023673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date May 02, 2003
Days to Decision 182 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
43d slower than avg
Panel avg: 139d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFB Conserver, Oxygen
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.