Cleared Traditional

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (K100950) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Venner Medical (Singapore) Pte, Ltd. devices

Submission Details

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
41d faster than avg
Panel avg: 139d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - BTO Tube, Tracheostomy (w/wo Connector)

All 127
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K100950.
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm
K242921 · Vitaltec Corporation · Jun 2025
Pilling Tracheostomy Tubes
K233713 · Teleflex Medical · Mar 2024
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