Cleared Traditional

K060945 - PORTEX PERCUTANEOUS TRACHEOSTOMY KIT

K060945 is an FDA 510(k) clearance for PORTEX PERCUTANEOUS TRACHEOSTOMY KIT, manufactured by Smiths Medical International. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K060945 · Smiths Medical International · Anesthesiology device
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Jun 2006
Decision
74d
Days
Class 2
Risk

K060945 is an FDA 510(k) clearance for the PORTEX PERCUTANEOUS TRACHEOSTOMY KIT. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Smiths Medical International (Rossendale, Lancashire, GB). The FDA issued a Cleared decision on June 19, 2006 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smiths Medical International devices

FDA 510(k) Submission Details - K060945

510(k) Number K060945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2006
Decision Date June 19, 2006
Days to Decision 74 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 140d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 59
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K060945.
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K173384 · Smiths Medical Ads, Inc. · Apr 2018
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283 · Cook, Inc. · Apr 2010
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K083031 · Smiths Medical Asd, Inc. · Aug 2009
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764 · Rusch Intl. · Jul 2002
CRICOTHYROTOMY TUBE
K983000 · Polamedco, Inc. · Oct 1999
CPR TRACHEOTOMY CARE TRAY
K960205 · Custom Pack Reliability · Aug 1996