Cleared Special

K101721 - WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101721 · Regulatory and Marketing Services, Inc. · Anesthesiology device
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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.

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Submission Details

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
140d slower than avg
Panel avg: 139d · This submission: 279d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.