Cleared Traditional

K140097 - AMT ENDOTRACHEAL TUBE BRIDLE RETENTION ...

K140097 is an FDA 510(k) clearance for AMT ENDOTRACHEAL TUBE BRIDLE RETENTION ..., manufactured by Applied Medical Technology, Inc.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 253-day FDA review.

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

FDA 510(k) Submission Details - K140097

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 140d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

CBH Device Classification - Class 1, General Controls

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.

Regulatory Peers - CBH Device, Fixation, Tracheal Tube

All 18
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K140097.
STABILTRACH
K935171 · B&B Medical Technologies, Inc. · Dec 1993
ADHESIVE E.T. TAPE
K925386 · B&B Medical Technologies, Inc. · Apr 1993
E.T. TAPE II
K912884 · B&B Medical Technologies, Inc. · Jul 1991
SALTER LABS MODEL #1015
K903539 · Salter Labs · Dec 1990
BABY E.T. TAPE II
K900912 · B&B Medical Technologies, Inc. · Aug 1990
E.T. TAPE II
K902065 · B&B Medical Technologies, Inc. · Jul 1990