Cleared Traditional

K153761 - Emergency Transtracheal Airway Catheter

K153761 is an FDA 510(k) clearance for Emergency Transtracheal Airway Catheter, manufactured by Cook Incorporated. The device is a Class 2 Anesthesiology device with product code BWC cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K153761 · Cook Incorporated · Anesthesiology device
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Sep 2016
Decision
267d
Days
Class 2
Risk

K153761 is an FDA 510(k) clearance for the Emergency Transtracheal Airway Catheter. Classified as Needle, Emergency Airway (product code BWC), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 22, 2016 after a review of 267 days - an extended review cycle.

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 Cook Incorporated devices

FDA 510(k) Submission Details - K153761

510(k) Number K153761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2015
Decision Date September 22, 2016
Days to Decision 267 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
127d slower than avg
Panel avg: 140d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWC Device Classification - Class 2, Special Controls

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 7
Devices cleared under the same product code (BWC) and FDA review panel - the closest regulatory comparables to K153761.
ScalpelCric
K200190 · VBM Medizintechnik GmbH · Oct 2020
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
K160200 · Cook Incorporated · Feb 2017
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