Cleared Special

K101721 - WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

K101721 is an FDA 510(k) clearance for WELL LEAD TRACHEOSTOMY TUBE AND DISPOSA..., manufactured by Regulatory and Marketing Services, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Special 510(k) pathway after a 279-day FDA review.

K101721 · Regulatory and Marketing Services, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
279d
Days
Class 2
Risk

K101721 is an FDA 510(k) clearance for the WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Regulatory and Marketing Services, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on March 24, 2011 after a review of 279 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K101721

510(k) Number K101721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2010
Decision Date March 24, 2011
Days to Decision 279 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
139d slower than avg
Panel avg: 140d · This submission: 279d
Pathway characteristics
Modification to existing cleared device.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 87
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K101721.
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
K192511 · Venner Medical (Singapore) Pte, Ltd. · Jul 2020
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K173384 · Smiths Medical Ads, Inc. · Apr 2018
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
K120079 · Primed Halberstadt Medizintechnik GmbH · May 2012
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
K100950 · Venner Medical (Singapore) Pte, Ltd. · Jul 2010
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
K100480 · Vitaltec Corporation · Jun 2010
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283 · Cook, Inc. · Apr 2010
K101721 · WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
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