Cleared Traditional

K131386 - EZ-OX PLUS GENERATION II

K131386 is an FDA 510(k) clearance for EZ-OX PLUS GENERATION II, manufactured by Air Liquide Healthcare America. The device is a Class 1 Anesthesiology device with product code ECX cleared through the Traditional 510(k) pathway after a 304-day FDA review.

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

FDA 510(k) Submission Details - K131386

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
164d slower than avg
Panel avg: 140d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

ECX Device Classification - Class 1, General Controls

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.