Cleared Traditional

K134023 - 2300 SERIES MGO PORTABLE OXYGEN

K134023 is an FDA 510(k) clearance for 2300 SERIES MGO PORTABLE OXYGEN, manufactured by Ultra Electronics Limited Precision Air & Land SY. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K134023 · Ultra Electronics Limited Precision Air & Land SY · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
116d
Days
Class 2
Risk

K134023 is an FDA 510(k) clearance for the 2300 SERIES MGO PORTABLE OXYGEN. 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 Ultra Electronics Limited Precision Air & Land SY (Cheltenham, Gloucestershire, GB). The FDA issued a Cleared decision on April 25, 2014 after a review of 116 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K134023

510(k) Number K134023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2013
Decision Date April 25, 2014
Days to Decision 116 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
24d faster than avg
Panel avg: 140d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

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 224
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K134023.
LONGFIAN OXYGEN CONCENTRATOR
K131968 · Longfian Scitech Co., Ltd. · Sep 2014
INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
K132489 · Inogen, Inc. · Jun 2014
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
K132205 · Inova Labs, Inc. · Jun 2014
OXYGEN GENERATOR LIQUEFIER - (OGL)
K131990 · Essex Cryogenics of Missouri, Inc. · Feb 2014
ROGS
K131016 · Molecular Products , Ltd. · Nov 2013
MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD
K123738 · Nidek Medical Products, Inc. · Feb 2013