Cleared Traditional

K050166 - PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

K050166 is the FDA 510(k) clearance for PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT by Smiths Medical. It is a Class 2 Anesthesiology device (product code BWC) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K050166 · Smiths Medical · Anesthesiology device
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May 2005
Decision
120d
Days
Class 2
Risk

K050166 is an FDA 510(k) clearance for the PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT. Classified as Needle, Emergency Airway (product code BWC), Class II - Special Controls.

Submitted by Smiths Medical (Hythe, Kent, GB). The FDA issued a Cleared decision on May 26, 2005 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5090 - 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 Smiths Medical devices

Submission Details

510(k) Number K050166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date May 26, 2005
Days to Decision 120 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
20d faster than avg
Panel avg: 140d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BWC Needle, Emergency Airway
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5090
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 - BWC Needle, Emergency Airway

All 8
Devices cleared under the same product code (BWC) and FDA review panel - the closest regulatory comparables to K050166.
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
K160200 · Cook Incorporated · Feb 2017
Emergency Transtracheal Airway Catheter
K153761 · Cook Incorporated · Sep 2016
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
K130405 · Teleflex Medical · Nov 2013
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
K013241 · Cook, Inc. · Feb 2002
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
K013252 · Cook, Inc. · Feb 2002
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
K013916 · Cook, Inc. · Dec 2001