Cleared Traditional

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) (K032112) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032112 · Portex , Ltd. · Anesthesiology device
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Jan 2004
Decision
201d
Days
Class 2
Risk

K032112 is an FDA 510(k) clearance for the P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Portex , Ltd. (England Ct21 6db, GB). The FDA issued a Cleared decision on January 26, 2004 after a review of 201 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 Portex , Ltd. devices

Submission Details

510(k) Number K032112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2003
Decision Date January 26, 2004
Days to Decision 201 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
61d slower than avg
Panel avg: 140d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K032112.
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
K080821 · Kimberly-Clark Corp. · Apr 2008
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K080170 · C.R. Bard, Inc. · Mar 2008
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
K071365 · C.R. Bard, Inc. · Nov 2007
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003
MODIFICATION TO LASER-SHIELD II
K993582 · Xomed, Inc. · Jan 2000
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K873461 · Mallinckrodt Critical Care · Nov 1987