Cleared Traditional

K081086 - 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 is an FDA 510(k) clearance for PORTEX BLUE LINE SACETT SUCTION ABOVE T..., manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K081086 · Smiths Medical Asd, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
119d
Days
Class 2
Risk

K081086 is an FDA 510(k) clearance for the PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6..... 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 August 13, 2008 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K081086

510(k) Number K081086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2008
Decision Date August 13, 2008
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
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 204
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K081086.
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
K080339 · Medsource International, LLC · Oct 2008
TRACHEOSCOPIC VENTILATION TUBE (TVT)
K082420 · Etview · Oct 2008
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · Mallinckrodt Medical · Oct 2008
WELL LEAD REINFORCED ENDOTRACHEAL TUBE
K073383 · Well Lead Medical Instruments · Jul 2008
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