Cleared Traditional

K010016 - MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER

K010016 is an FDA 510(k) clearance for MELKER CUFFED EMERGENCY CRICOTHYROTOMY ..., 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 280-day FDA review.

K010016 · Cook, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
280d
Days
Class 2
Risk

K010016 is an FDA 510(k) clearance for the MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER. 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 October 9, 2001 after a review of 280 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, Inc. devices

FDA 510(k) Submission Details - K010016

510(k) Number K010016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2001
Decision Date October 09, 2001
Days to Decision 280 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
140d slower than avg
Panel avg: 140d · This submission: 280d
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.