Cleared Traditional

K063354 - LINDE INTEGRATED VALVE (LIV) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K063354 · Linde Gas Therapeutics · Anesthesiology device
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Apr 2007
Decision
162d
Days
Class 1
Risk

K063354 is an FDA 510(k) clearance for the LINDE INTEGRATED VALVE (LIV). Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Linde Gas Therapeutics (Broadview Heights, US). The FDA issued a Cleared decision on April 17, 2007 after a review of 162 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 Therapeutics devices

Submission Details

510(k) Number K063354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date April 17, 2007
Days to Decision 162 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
23d slower than avg
Panel avg: 139d · This submission: 162d
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.