Cleared Traditional

K132489 - INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)

K132489 is an FDA 510(k) clearance for INOGEN AT HOME OXYGEN CONCENTRATOR (AKA..., manufactured by Inogen, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K132489 · Inogen, Inc. · Anesthesiology device
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Jun 2014
Decision
316d
Days
Class 2
Risk

K132489 is an FDA 510(k) clearance for the INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME). 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 Inogen, Inc. (Goleta, US). The FDA issued a Cleared decision on June 20, 2014 after a review of 316 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.

View all Inogen, Inc. devices

FDA 510(k) Submission Details - K132489

510(k) Number K132489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2013
Decision Date June 20, 2014
Days to Decision 316 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
176d slower than avg
Panel avg: 140d · This submission: 316d
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 209
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K132489.
Deployable Oxygen Generation System-Smaill (DOGS-S)
K150930 · Airsep Corporation · Dec 2015
PUREFILL OXYGEN COMPRESSOR
K141967 · Inovo, Inc. · Nov 2014
LONGFIAN OXYGEN CONCENTRATOR
K131968 · Longfian Scitech Co., Ltd. · Sep 2014
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
K132205 · Inova Labs, 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