Cleared Special

K082420 - TRACHEOSCOPIC VENTILATION TUBE (TVT)

K082420 is an FDA 510(k) clearance for TRACHEOSCOPIC VENTILATION TUBE (TVT), manufactured by Etview. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Special 510(k) pathway after a 47-day FDA review.

K082420 · Etview · Anesthesiology device
Download Printable Device Report (PDF)
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Oct 2008
Decision
47d
Days
Class 2
Risk

K082420 is an FDA 510(k) clearance for the TRACHEOSCOPIC VENTILATION TUBE (TVT). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Etview (Binyamina, IL). The FDA issued a Cleared decision on October 8, 2008 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Etview devices

FDA 510(k) Submission Details - K082420

510(k) Number K082420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2008
Decision Date October 08, 2008
Days to Decision 47 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 140d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 151
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K082420.
TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
K091761 · Teleflexmedical, Inc. · Oct 2009
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
K083119 · Smiths Medical Asd, Inc. · Jun 2009
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K090352 · Covidien · Apr 2009
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · Mallinckrodt Medical · Oct 2008
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
K081086 · Smiths Medical Asd, Inc. · Aug 2008
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
K080821 · Kimberly-Clark Corp. · Apr 2008