Cleared Traditional

OXYGEN GENERATOR LIQUEFIER - (OGL) (K131990) - FDA 510(k) Clearance

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

K131990 · Essex Cryogenics of Missouri, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
238d
Days
Class 2
Risk

K131990 is an FDA 510(k) clearance for the OXYGEN GENERATOR LIQUEFIER - (OGL). Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Essex Cryogenics of Missouri, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 21, 2014 after a review of 238 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 Cryogenics of Missouri, Inc. devices

Submission Details

510(k) Number K131990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2013
Decision Date February 21, 2014
Days to Decision 238 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
98d slower than avg
Panel avg: 140d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 48
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K131990.
O2 Concepts Oxlife Independence Model 301-0001
K182454 · O2 Concepts, LLC · Dec 2018
Oxygen Concentrator
K172234 · Sysmed (China) Co., Ltd. · Jun 2018
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
K172648 · Devilbiss Healthcare, LLC · Mar 2018
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · Respironics, Inc. · Nov 2011
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028 · Respironics, Inc. · Jul 2009
HOMELOX
K081206 · Respironics, Inc. · Jul 2008