Cleared Traditional

K925386 - ADHESIVE E.T. TAPE

K925386 is an FDA 510(k) clearance for ADHESIVE E.T. TAPE, manufactured by B&B Medical Technologies, Inc.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K925386 · B&B Medical Technologies, Inc. · Anesthesiology device
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Apr 1993
Decision
175d
Days
Class 1
Risk

K925386 is an FDA 510(k) clearance for the ADHESIVE E.T. TAPE. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by B&B Medical Technologies, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on April 19, 1993 after a review of 175 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 B&B Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K925386

510(k) Number K925386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 26, 1992
Decision Date April 19, 1993
Days to Decision 175 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
35d slower than avg
Panel avg: 140d · This submission: 175d
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 K925386.
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
K140097 · Applied Medical Technology, Inc. · Sep 2014
STABILTRACH
K935171 · B&B Medical Technologies, Inc. · Dec 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