Cleared Abbreviated

PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) (K022684) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K022684 · Essex Cryogenics of Missouri, Inc. · Anesthesiology device
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Sep 2002
Decision
30d
Days
Class 2
Risk

K022684 is an FDA 510(k) clearance for the PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS). Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Essex Cryogenics of Missouri, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Essex Cryogenics of Missouri, Inc. devices

Submission Details

510(k) Number K022684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2002
Decision Date September 11, 2002
Days to Decision 30 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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.