Cleared Traditional

K110269 - WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL

K110269 is an FDA 510(k) clearance for WELL LEAD ENDOTRACHEAL TUBE WITH EVACUA..., manufactured by Well Lead Medical Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K110269 · Well Lead Medical Co., Ltd. · Anesthesiology device
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Aug 2011
Decision
211d
Days
Class 2
Risk

K110269 is an FDA 510(k) clearance for the WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Appollo Beach, US). The FDA issued a Cleared decision on August 26, 2011 after a review of 211 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Co., Ltd. devices

FDA 510(k) Submission Details - K110269

510(k) Number K110269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2011
Decision Date August 26, 2011
Days to Decision 211 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
71d slower than avg
Panel avg: 140d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 190
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