Cleared Traditional Expedited

K033000 - NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033000 · Essex Cryogenics of Missouri, Inc. · Anesthesiology device
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Mar 2004
Decision
179d
Days
Class 2
Risk

K033000 is an FDA 510(k) clearance for the NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Essex Cryogenics of Missouri, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 179 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5655 - 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 Essex Cryogenics of Missouri, Inc. devices

Submission Details

510(k) Number K033000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2003
Decision Date March 22, 2004
Days to Decision 179 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
40d slower than avg
Panel avg: 139d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYJ Unit, Liquid-oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5655
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.