Cleared Traditional

K032143 - LIQUID OXYGEN SYSTEM

K032143 is an FDA 510(k) clearance for LIQUID OXYGEN SYSTEM, manufactured by Micro Technology Services, Inc.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K032143 · Micro Technology Services, Inc. · Anesthesiology device
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Mar 2004
Decision
260d
Days
Class 2
Risk

K032143 is an FDA 510(k) clearance for the LIQUID OXYGEN SYSTEM. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Micro Technology Services, Inc. (Richardson, US). The FDA issued a Cleared decision on March 30, 2004 after a review of 260 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.

FDA 510(k) Submission Details - K032143

510(k) Number K032143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2003
Decision Date March 30, 2004
Days to Decision 260 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 140d · This submission: 260d
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 53
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K032143.
SPIRIT, MODEL HAS
K050153 · Caire, Inc. · Apr 2005
PLIX
K050414 · Respironics, Inc. · Apr 2005
PRECISION LIQUID OXYGEN SYSTEM
K041122 · Precision Medical, Inc. · Oct 2004
NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
K033000 · Essex Cryogenics of Missouri, Inc. · Mar 2004
SPIRIT 300
K013251 · Caire, Inc. · Dec 2001
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
K993220 · Puritan Bennett Corp. · Oct 1999
K032143 · LIQUID OXYGEN SYSTEM
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