Cleared Traditional

K800498 - ADULT ANESTHESIA BREATHING CIRCUITS . . (FDA 510(k) Clearance)

Class I Anesthesiology device.

K800498 · Airlife, Inc. · Anesthesiology device
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Mar 1980
Decision
21d
Days
Class 1
Risk

K800498 is an FDA 510(k) clearance for the ADULT ANESTHESIA BREATHING CIRCUITS . .. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 K800498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date March 25, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 139d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.