Cleared Traditional

K101792 - LIV LINDE INTERGRATED VALVE-PORTABLE OX...

K101792 is an FDA 510(k) clearance for LIV LINDE INTERGRATED VALVE-PORTABLE OX..., manufactured by Linde Gas North America, LLC. The device is a Class 1 Anesthesiology device with product code ECX cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K101792 · Linde Gas North America, LLC · Anesthesiology device
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Mar 2011
Decision
263d
Days
Class 1
Risk

K101792 is an FDA 510(k) clearance for the LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706. Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Linde Gas North America, LLC (Murray Hill, US). The FDA issued a Cleared decision on March 18, 2011 after a review of 263 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. 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. Standard predicate reliance. 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 Linde Gas North America, LLC devices

FDA 510(k) Submission Details - K101792

510(k) Number K101792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2010
Decision Date March 18, 2011
Days to Decision 263 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
123d slower than avg
Panel avg: 140d · This submission: 263d
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.