510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050166Substantially Equivalent

Portex Emergency Cricothyroidotomy Kit

Abbott Medical, Hythe, Kent, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050166 is the FDA 510(k) clearance record for PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT, a class II device, cleared for Smiths Medical on under FDA product code BWC (Needle, Emergency Airway). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K050166.

Clearance record

Decision date
Received
(120 days to decision)
Product code
BWC Needle, Emergency Airway
Regulation
21 CFR 868.5090
Device class
Class II
Review panel
Anesthesiology
Applicant
Smiths Medical Military Rd., Hythe, Kent, GB
510(k) summary
Summary PDF
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