Cleared Traditional

K132205 - ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM

K132205 is an FDA 510(k) clearance for ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM, manufactured by Inova Labs, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K132205 · Inova Labs, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
325d
Days
Class 2
Risk

K132205 is an FDA 510(k) clearance for the ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM. 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 Inova Labs, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on June 6, 2014 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K132205

510(k) Number K132205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2013
Decision Date June 06, 2014
Days to Decision 325 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
185d slower than avg
Panel avg: 140d · This submission: 325d
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 K132205.
PUREFILL OXYGEN COMPRESSOR
K141967 · Inovo, Inc. · Nov 2014
LONGFIAN OXYGEN CONCENTRATOR
K131968 · Longfian Scitech Co., Ltd. · Sep 2014
INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
K132489 · Inogen, Inc. · Jun 2014
2300 SERIES MGO PORTABLE OXYGEN
K134023 · Ultra Electronics Limited Precision Air & Land SY · Apr 2014
OXYGEN GENERATOR LIQUEFIER - (OGL)
K131990 · Essex Cryogenics of Missouri, Inc. · Feb 2014
ROGS
K131016 · Molecular Products , Ltd. · Nov 2013