510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010016Substantially Equivalent

Melker Cuffed Emergency Cricothyrotomy Catheter

Cook Inc., Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010016 is the FDA 510(k) clearance record for MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER, a class II device, cleared for Cook, Inc. on under FDA product code BWC (Needle, Emergency Airway). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show one recall naming K010016.

Clearance record

Decision date
Received
(280 days to decision)
Product code
BWC Needle, Emergency Airway
Regulation
21 CFR 868.5090
Device class
Class II
Review panel
Anesthesiology
Applicant
Cook, Inc. 925 S. Curry Pike, Bloomington IN
510(k) summary
Summary
Third party review
No

Clearances, product code BWC

Trailing 12 months

FDA records hold no clearances under product code BWC in the trailing twelve months.

FDA records show no clearances under product code BWC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260