Cleared Traditional

K942392 - AIRWAY CONNECTOR WITH FLEX TUBE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K942392 · Mallinckrodt Medical · Anesthesiology device
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Aug 1994
Decision
95d
Days
Class 1
Risk

K942392 is an FDA 510(k) clearance for the AIRWAY CONNECTOR WITH FLEX TUBE. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Mallinckrodt Medical (Argyle, US). The FDA issued a Cleared decision on August 22, 1994 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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.

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Submission Details

510(k) Number K942392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date August 22, 1994
Days to Decision 95 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
44d faster than avg
Panel avg: 139d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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.