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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 82
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K042684.
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
K060945 · Smiths Medical International · Jun 2006
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
K051587 · Tracoe Medical GmbH · Oct 2005
CS MEDICAL ADULT TTCF CATHETER
K050379 · Cs Medical, Inc. · Jul 2005
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
K031553 · Arcadia Medical Corporation · Nov 2003
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
K030570 · Portex , Ltd. · Sep 2003
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
K030381 · Portex , Ltd. · Aug 2003