Cleared Traditional

K100950 - VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE

K100950 is an FDA 510(k) clearance for VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE, manufactured by Venner Medical (Singapore) Pte, Ltd.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K100950 · Venner Medical (Singapore) Pte, Ltd. · Anesthesiology device
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Jul 2010
Decision
98d
Days
Class 2
Risk

K100950 is an FDA 510(k) clearance for the VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Venner Medical (Singapore) Pte, Ltd. (Dallas, US). The FDA issued a Cleared decision on July 13, 2010 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K100950

510(k) Number K100950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2010
Decision Date July 13, 2010
Days to Decision 98 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
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 128
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K100950.
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
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PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
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K100950 · VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
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