Cleared Traditional

K033897 - MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K033897 · Aga-Linde Health Care · Anesthesiology device
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Jul 2004
Decision
216d
Days
Class 1
Risk

K033897 is an FDA 510(k) clearance for the MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM. Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Aga-Linde Health Care (Solon, US). The FDA issued a Cleared decision on July 19, 2004 after a review of 216 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.

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Submission Details

510(k) Number K033897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2003
Decision Date July 19, 2004
Days to Decision 216 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
77d slower than avg
Panel avg: 139d · This submission: 216d
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.