Cleared Traditional

K063354 - LINDE INTEGRATED VALVE (LIV)

K063354 is an FDA 510(k) clearance for LINDE INTEGRATED VALVE (LIV), manufactured by Linde Gas Therapeutics. The device is a Class 1 Anesthesiology device with product code ECX cleared through the Traditional 510(k) pathway after a 162-day FDA review.

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

FDA 510(k) Submission Details - K063354

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
22d slower than avg
Panel avg: 140d · This submission: 162d
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.