Cleared Traditional

K130304 - LMA FAMILY OF AIRWAYS (FDA 510(k) Clearance)

Class I Anesthesiology device.

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

K130304 is an FDA 510(k) clearance for the LMA FAMILY OF AIRWAYS. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by The Laryngeal Mask Co., Ltd. (Research Triangle Park, US). The FDA issued a Cleared decision on May 30, 2014 after a review of 477 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all The Laryngeal Mask Co., Ltd. devices

Submission Details

510(k) Number K130304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 139d · This submission: 477d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.