Cleared Traditional Expedited

K113767 - MOUNTED MEDICAL OXYGEN SYSTEM

K113767 is an FDA 510(k) clearance for MOUNTED MEDICAL OXYGEN SYSTEM, manufactured by Essex Industries, Inc.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K113767 · Essex Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K113767

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
Combination Product No
PCCP Authorized No
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.

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 32
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K113767.
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
K130068 · Essex Industries, Inc. D/B/A Essex Cryogenics of M · Jul 2013
PRECISION LIQUID OXYGEN SYSTEM
K103324 · Precision Medical, Inc. · Apr 2011
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
K101272 · Essex Industries, Inc. · Aug 2010
GOLOX-93
K081779 · Respironics, Inc. · Sep 2008
MODIFICATION TO: SPIRIT
K080023 · Caire, Inc. · Jun 2008
RESPIRONICS GOLOX
K072723 · Respironics, Inc. · Mar 2008