Cleared Abbreviated

K083119 - PORTEX TRACHEAL TUBE

K083119 is an FDA 510(k) clearance for PORTEX TRACHEAL TUBE, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Abbreviated 510(k) pathway after a 247-day FDA review.

K083119 · Smiths Medical Asd, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
247d
Days
Class 2
Risk

K083119 is an FDA 510(k) clearance for the PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Hythe, Kent, GB). The FDA issued a Cleared decision on June 26, 2009 after a review of 247 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K083119

510(k) Number K083119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2008
Decision Date June 26, 2009
Days to Decision 247 days
Submission Type Abbreviated
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
107d slower than avg
Panel avg: 140d · This submission: 247d
Pathway characteristics
Standards-based clearance path.

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 149
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K083119.
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TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K090352 · Covidien · Apr 2009
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · Mallinckrodt Medical · Oct 2008
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
K081086 · Smiths Medical Asd, Inc. · Aug 2008