Cleared Traditional

K942392 - AIRWAY CONNECTOR WITH FLEX TUBE

K942392 is an FDA 510(k) clearance for AIRWAY CONNECTOR WITH FLEX TUBE, manufactured by Mallinckrodt Medical. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 95-day FDA review.

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.

View all Mallinckrodt Medical devices

FDA 510(k) Submission Details - K942392

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 140d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

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.

Regulatory Peers - BZA Connector, Airway (extension)

All 58
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K942392.
PRIMA, INC. VENTILATOR HOSES
K944532 · Prima, Inc. · Dec 1994
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
K944534 · Prima, Inc. · Nov 1994
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
K944535 · Prima, Inc. · Nov 1994
MAG CONNECTORS AND AIRWAY EXTENSIONS
K931800 · Mag, Inc. · May 1993
CONNECTORS AND AIRWAY EXTENSIONS
K931036 · Life Shield Healthcare Products, Inc. · Apr 1993
CONNECTORS AND AIRWAY EXTENSIONS
K931038 · Med-Plastics Intl., Inc. · Apr 1993