Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004672275

FEI Number

3004672275

Entity Name

INOGEN, INC.

City/State/Country

Goleta, CA, US

Establishment Address

859 Ward Drive, Suite 200, Goleta, CA 93111, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

INOGEN, INC. (Owner Number: 9064201)

Owner / Operator Contact Address

859 Ward Drive, Suite 200, Goleta, CA 93111, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132489

PMA Number

N/A

All Registered Proprietary Names

Aurora Inogen Rove 4 Portable Oxygen Concentrator INOGEN ONE G3 OXYGEN CONCENTRATOR OxyGo Fit INOGEN ONE G4 OXYGEN CONCENTRATOR INOGEN ONE OXYGEN CONCENTRATOR INOGEN ONE G5 OXYGEN CONCENTRATOR INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR OxyGo OxyGo NEXT OxyGo Fit BLUETOOTH INOGEN ONE G2 OXYGEN CONCENTRATOR TAV System Inogen Rove 6 Portable Oxygen Concentrator Voxi 5 Inogen At Home GS 100 Oxygen Concentrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2025-06-18
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-03-20
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2004-06-16
ONZ	Mechanical Ventilator	Anesthesiology	Class 2	868.5895	2019-08-16
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-07-03
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2025-04-25
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2014-10-16

Official Correspondent

Elias Cury

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INOGEN, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3019385742	Inogen, Inc	Plano, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004672275. Last updated year: 2026. Please use registration number 3004672275 when referencing this establishment in official correspondence.