Cleared Traditional

K161179 - Intelli-Ox

K161179 is an FDA 510(k) clearance for Intelli-Ox, manufactured by Air Liquide Healthcare America Corporation. The device is a Class 1 Anesthesiology device with product code ECX cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K161179 · Air Liquide Healthcare America Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
352d
Days
Class 1
Risk

K161179 is an FDA 510(k) clearance for the Intelli-Ox. Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Air Liquide Healthcare America Corporation (Houston, US). The FDA issued a Cleared decision on April 13, 2017 after a review of 352 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.

FDA 510(k) Submission Details - K161179

510(k) Number K161179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2016
Decision Date April 13, 2017
Days to Decision 352 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 140d · This submission: 352d
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.

Regulatory Peers - ECX Cylinder, Compressed Gas, And Valve

All 11
Devices cleared under the same product code (ECX) and FDA review panel - the closest regulatory comparables to K161179.
Walk-O2-Bout
K161472 · Essex Industries, Inc. · Nov 2016
Medipure Oxygen-LC System
K153518 · Praxair Distribution, Incorporated. · Jun 2016
Intelli-Ox
K143060 · Air Liquide Healthcare · May 2015
OXYTOTE INFINITY SERIES VIPR SYSTEMS
K142149 · Western/Scott Fetzer Co. · Apr 2015
GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
K132778 · Praxair Healthcare Services · Jul 2014
EZ-OX PLUS GENERATION II
K131386 · Air Liquide Healthcare America · Mar 2014