Cleared Traditional

K131386 - EZ-OX PLUS GENERATION II (FDA 510(k) Clearance)

Class I Anesthesiology device.

K131386 · Air Liquide Healthcare America · Anesthesiology device
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Mar 2014
Decision
304d
Days
Class 1
Risk

K131386 is an FDA 510(k) clearance for the EZ-OX PLUS GENERATION II. Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Air Liquide Healthcare America (Houston, US). The FDA issued a Cleared decision on March 14, 2014 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Air Liquide Healthcare America devices

Submission Details

510(k) Number K131386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2013
Decision Date March 14, 2014
Days to Decision 304 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
165d slower than avg
Panel avg: 139d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECX Cylinder, Compressed Gas, And Valve
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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.