Cleared Traditional

K954446 - AUGUSTINE INTUBATION GUIDE

K954446 is an FDA 510(k) clearance for AUGUSTINE INTUBATION GUIDE, manufactured by Augustine Medical, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K954446 · Augustine Medical, Inc. · Anesthesiology device
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Dec 1995
Decision
95d
Days
Class 1
Risk

K954446 is an FDA 510(k) clearance for the AUGUSTINE INTUBATION GUIDE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Augustine Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 29, 1995 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 868.5540 - 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 Augustine Medical, Inc. devices

FDA 510(k) Submission Details - K954446

510(k) Number K954446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date December 29, 1995
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.

CCW Device Classification - Class 1, General Controls

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
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 - CCW Laryngoscope, Rigid

All 14
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K954446.
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K945425 · Rudolf Riester GmbH & Co. KG · Mar 1995
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K915161 · Augustine Medical, Inc. · May 1992
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K921166 · Augustine Medical, Inc. · Apr 1992