Cleared Traditional

K880183 - PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT

K880183 is an FDA 510(k) clearance for PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT, manufactured by Essex Cryogenics of Missouri, Inc.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K880183 · Essex Cryogenics of Missouri, Inc. · Anesthesiology device
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Apr 1988
Decision
90d
Days
Class 2
Risk

K880183 is an FDA 510(k) clearance for the PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT. 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 April 14, 1988 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K880183

510(k) Number K880183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1988
Decision Date April 14, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYJ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BYJ Unit, Liquid-oxygen, Portable

All 21
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K880183.
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COMPANION LIQUID OXYGEN SYSTEM
K861503 · Puritan Bennett Corp. · Jun 1986
MARK 4 LIQUID OXYGEN SYSTEM
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LIQUID OXYGEN SYSTEM
K840534 · The John Bunn Co. · Mar 1984