Cleared Traditional Expedited

MOUNTED MEDICAL OXYGEN SYSTEM (K113767) - FDA 510(k) Clearance

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

K113767 · Essex Industries, Inc. · Anesthesiology device
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Jun 2012
Decision
191d
Days
Class 2
Risk

K113767 is an FDA 510(k) clearance for the MOUNTED MEDICAL OXYGEN SYSTEM. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Essex Industries, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 29, 2012 after a review of 191 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. devices

Submission Details

510(k) Number K113767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date June 29, 2012
Days to Decision 191 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
51d slower than avg
Panel avg: 140d · This submission: 191d
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 K113767.
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