Cleared Traditional

K101272 - MASS OXYGEN DISTRIBUTION SYSTEM (MODS) ...

K101272 is an FDA 510(k) clearance for MASS OXYGEN DISTRIBUTION SYSTEM (MODS) ..., 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 106-day FDA review.

K101272 · Essex Industries, Inc. · Anesthesiology device
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Aug 2010
Decision
106d
Days
Class 2
Risk

K101272 is an FDA 510(k) clearance for the MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3. 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 August 20, 2010 after a review of 106 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 Industries, Inc. devices

FDA 510(k) Submission Details - K101272

510(k) Number K101272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2010
Decision Date August 20, 2010
Days to Decision 106 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
34d faster than avg
Panel avg: 140d · This submission: 106d
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 K101272.
PRECISION LIQUID OXYGEN SYSTEM
K103324 · Precision Medical, Inc. · Apr 2011
GOLOX-93
K081779 · Respironics, Inc. · Sep 2008
RESPIRONICS GOLOX
K072723 · Respironics, Inc. · Mar 2008
PLIX
K050414 · Respironics, Inc. · Apr 2005
PRECISION LIQUID OXYGEN SYSTEM
K041122 · Precision Medical, Inc. · Oct 2004
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
K993220 · Puritan Bennett Corp. · Oct 1999