Cleared Traditional

K013916 - MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET

K013916 is an FDA 510(k) clearance for MELKER EMERGENCY CRICOTHYROTOMY CATHETE..., manufactured by Cook, Inc.. The device is a Class 2 Anesthesiology device with product code BWC cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K013916 · Cook, Inc. · Anesthesiology device
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Dec 2001
Decision
23d
Days
Class 2
Risk

K013916 is an FDA 510(k) clearance for the MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET. Classified as Needle, Emergency Airway (product code BWC), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 20, 2001 after a review of 23 days - a notably fast clearance 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: 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 Cook, Inc. devices

FDA 510(k) Submission Details - K013916

510(k) Number K013916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2001
Decision Date December 20, 2001
Days to Decision 23 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
117d faster than avg
Panel avg: 140d · This submission: 23d
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 9
Devices cleared under the same product code (BWC) and FDA review panel - the closest regulatory comparables to K013916.
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
K050166 · Smiths Medical · May 2005
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
K013241 · Cook, Inc. · Feb 2002
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
K013252 · Cook, Inc. · Feb 2002
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
K010016 · Cook, Inc. · Oct 2001
KEY CHAIN EMERGENCY AIRWAY
K962312 · Ffrench Pocket Emergency Airway, Inc. · Jun 1997