Cleared Traditional

K953400 - GUEDEL AIRWAY

K953400 is the FDA 510(k) clearance for GUEDEL AIRWAY by Mallinckrodt Medical. It is a Class 1 Anesthesiology device (product code CAE) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K953400 · Mallinckrodt Medical · Anesthesiology device
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Oct 1995
Decision
96d
Days
Class 1
Risk

K953400 is an FDA 510(k) clearance for the GUEDEL AIRWAY. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on October 24, 1995 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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

Submission Details

510(k) Number K953400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1995
Decision Date October 24, 1995
Days to Decision 96 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 140d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
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 - CAE Airway, Oropharyngeal, Anesthesiology

All 12
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K953400.
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K955721 · Mallinckrodt Medical · Mar 1997
RUSCH OPTOSAFE
K960240 · Rusch Intl. · Apr 1996
CURITY FIBEROPTIC INTUBATING AIRWAY
K855137 · The Kendal Co. · Mar 1986
DISPOSABLE GUEDEL AIRWAY
K850248 · Inmed Corp. · Mar 1985
RESPIRONICS VENT EASY OXYGEN ENRICHME
K842605 · Respironics, Inc. · Jul 1984
RESPIRONICS RESCUE DOME
K833328 · Respironics, Inc. · Dec 1983