Cleared Traditional

LMA FAMILY OF AIRWAYS

K130304 · The Laryngeal Mask Co., Ltd. · Anesthesiology
May 2014
Decision
477d
Days
Class 1
Risk

About This 510(k) Submission

K130304 is an FDA 510(k) clearance for the LMA FAMILY OF AIRWAYS, a Airway, Oropharyngeal, Anesthesiology (Class I — General Controls, product code CAE), submitted by The Laryngeal Mask Co., Ltd. (Research Triangle Park, US). The FDA issued a Cleared decision on May 30, 2014, 477 days after receiving the submission on February 7, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5110.

Submission Details

510(k) Number K130304 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2013
Decision Date May 30, 2014
Days to Decision 477 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAE — Airway, Oropharyngeal, Anesthesiology
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5110

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