Cleared Traditional

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (K130068) - FDA 510(k) Clearance

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

K130068 · Essex Industries, Inc. D/B/A Essex Cryogenics of M · Anesthesiology device
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Jul 2013
Decision
189d
Days
Class 2
Risk

K130068 is an FDA 510(k) clearance for the DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS). Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Essex Industries, Inc. D/B/A Essex Cryogenics of M (St. Louis, US). The FDA issued a Cleared decision on July 19, 2013 after a review of 189 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 Industries, Inc. D/B/A Essex Cryogenics of M devices

Submission Details

510(k) Number K130068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2013
Decision Date July 19, 2013
Days to Decision 189 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
49d slower than avg
Panel avg: 140d · This submission: 189d
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.

Regulatory Peers - BYJ Unit, Liquid-oxygen, Portable

All 11
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K130068.
GOLOX-93
K081779 · Respironics, Inc. · Sep 2008
RESPIRONICS GOLOX
K072723 · Respironics, Inc. · Mar 2008
PLIX
K050414 · Respironics, Inc. · Apr 2005
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
K993220 · Puritan Bennett Corp. · Oct 1999
PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT
K933930 · Puritan Bennett Corp. · Mar 1994
MOBILAIRE LIQUID OXYGEN SYSTEMS
K926267 · Invacare Corp. · Aug 1993