Cleared Special

K090352 - TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES

K090352 is an FDA 510(k) clearance for TAPERGUARD ENDOTRACHEAL TUBES, manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Special 510(k) pathway after a 51-day FDA review.

K090352 · Covidien · Anesthesiology device
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Apr 2009
Decision
51d
Days
Class 2
Risk

K090352 is an FDA 510(k) clearance for the TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on April 3, 2009 after a review of 51 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 Covidien devices

FDA 510(k) Submission Details - K090352

510(k) Number K090352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2009
Decision Date April 03, 2009
Days to Decision 51 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 140d · This submission: 51d
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 190
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K090352.
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
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
K091591 · Flexicare Medical, Ltd. · Jun 2009
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
K082038 · Clarus Medical, LLC · Apr 2009
ENDOTRACHEAL TUBE
K080105 · Chilecom Medical Devices Co., Ltd. · Feb 2009
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
K080339 · Medsource International, LLC · Oct 2008
TRACHEOSCOPIC VENTILATION TUBE (TVT)
K082420 · Etview · Oct 2008