Cleared Traditional

K140097 - AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K140097 · Applied Medical Technology, Inc. · Anesthesiology device
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Sep 2014
Decision
253d
Days
Class 1
Risk

K140097 is an FDA 510(k) clearance for the AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on September 24, 2014 after a review of 253 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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 Applied Medical Technology, Inc. devices

Submission Details

510(k) Number K140097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2014
Decision Date September 24, 2014
Days to Decision 253 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 139d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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.