Cleared Traditional

K080339 - MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)

K080339 is an FDA 510(k) clearance for MEDSOURCE ENDOTRACHEAL TUBE (WITH AND W..., manufactured by Medsource International, LLC. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K080339 · Medsource International, LLC · Anesthesiology device
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Oct 2008
Decision
262d
Days
Class 2
Risk

K080339 is an FDA 510(k) clearance for the MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Medsource International, LLC (Indianapolis, US). The FDA issued a Cleared decision on October 27, 2008 after a review of 262 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 Medsource International, LLC devices

FDA 510(k) Submission Details - K080339

510(k) Number K080339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2008
Decision Date October 27, 2008
Days to Decision 262 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
122d slower than avg
Panel avg: 140d · This submission: 262d
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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