Cleared Special

K153518 - Medipure Oxygen-LC System (FDA 510(k) Clearance)

Class I Anesthesiology device.

K153518 · Praxair Distribution, Incorporated. · Anesthesiology device
Download Printable Device Report (PDF)
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Jun 2016
Decision
178d
Days
Class 1
Risk

K153518 is an FDA 510(k) clearance for the Medipure Oxygen-LC System. Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Praxair Distribution, Incorporated. (Tonawanda, US). The FDA issued a Cleared decision on June 3, 2016 after a review of 178 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Praxair Distribution, Incorporated. devices

Submission Details

510(k) Number K153518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2015
Decision Date June 03, 2016
Days to Decision 178 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 139d · This submission: 178d
Pathway characteristics
Modification to existing cleared device.

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.