Cleared Traditional

Emergency Transtracheal Airway Catheter (K153761) - FDA 510(k) Clearance

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

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

Submission Details

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.

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

Devices cleared under the same product code (BWC) and FDA review panel - the closest regulatory comparables to K153761.
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MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
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MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
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