Cleared Traditional

K042684 - WELL LEAD TRACHEOSTOMY TUBE

K042684 is an FDA 510(k) clearance for WELL LEAD TRACHEOSTOMY TUBE, manufactured by Well Lead Medical Instruments. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K042684 · Well Lead Medical Instruments · Anesthesiology device
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Feb 2005
Decision
141d
Days
Class 2
Risk

K042684 is an FDA 510(k) clearance for the WELL LEAD TRACHEOSTOMY TUBE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Well Lead Medical Instruments (Apollo Beach, US). The FDA issued a Cleared decision on February 17, 2005 after a review of 141 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 Well Lead Medical Instruments devices

FDA 510(k) Submission Details - K042684

510(k) Number K042684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date February 17, 2005
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 140d · This submission: 141d
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 59
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K042684.
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K173384 · Smiths Medical Ads, Inc. · Apr 2018
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283 · Cook, Inc. · Apr 2010
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K083031 · Smiths Medical Asd, Inc. · Aug 2009
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764 · Rusch Intl. · Jul 2002
CRICOTHYROTOMY TUBE
K983000 · Polamedco, Inc. · Oct 1999
CPR TRACHEOTOMY CARE TRAY
K960205 · Custom Pack Reliability · Aug 1996