Cleared Traditional

K802323 - PEDIATRIC OXYGEN OR AEROSOL MASKS, (FDA 510(k) Clearance)

Class I Anesthesiology device.

K802323 · Airlife, Inc. · Anesthesiology device
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Oct 1980
Decision
10d
Days
Class 1
Risk

K802323 is an FDA 510(k) clearance for the PEDIATRIC OXYGEN OR AEROSOL MASKS,. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Airlife, Inc. (Walker, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Airlife, Inc. devices

Submission Details

510(k) Number K802323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date October 03, 1980
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 139d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.