Cleared Traditional

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

K050166 · Smiths Medical · Anesthesiology
May 2005
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K050166 is an FDA 510(k) clearance for the PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT, a Needle, Emergency Airway (Class II — Special Controls, product code BWC), submitted by Smiths Medical (Hythe, Kent, GB). The FDA issued a Cleared decision on May 26, 2005, 120 days after receiving the submission on January 26, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5090.

Submission Details

510(k) Number K050166 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2005
Decision Date May 26, 2005
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWC — Needle, Emergency Airway
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5090

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