Cleared Traditional

K950930 - TRACHE-TITE

K950930 is an FDA 510(k) clearance for TRACHE-TITE, manufactured by The Varner Group, Inc.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K950930 · The Varner Group, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
21d
Days
Class 1
Risk

K950930 is an FDA 510(k) clearance for the TRACHE-TITE. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by The Varner Group, Inc. (Washington, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Varner Group, Inc. devices

FDA 510(k) Submission Details - K950930

510(k) Number K950930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1995
Decision Date March 22, 1995
Days to Decision 21 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
119d faster than avg
Panel avg: 140d · This submission: 21d
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 21
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K950930.
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
K140097 · Applied Medical Technology, Inc. · Sep 2014
DALE ENDOTRACHEAL TUBE HOLDER 270/280
K964399 · Dale Medical Products, Inc. · Jan 1997
FLEX BLUE
K950318 · King Systems Corp. · Feb 1995
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