Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019385742

FEI Number

3009843463

Entity Name

Inogen, Inc

City/State/Country

Plano, TX, US

Establishment Address

600 Shiloh Rd., Plano, TX 75074, US

Establishment Type(s)

Repack or Relabel Medical Device

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

K203347

PMA Number

N/A

All Registered Proprietary Names

Inogen At Home GS 100 Oxygen Concentrator Inogen Rove 4 Portable Oxygen Concentrator Inogen Rove 6 Portable Oxygen Concentrator SIMEOX 200 Airway Clearance Device 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 Aurora

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2014-10-16
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-03-20
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-07-03
SDT	Intra-Pulmonary Percussive Vibration (Ipv) Devices	Anesthesiology	Class 2	868.5665	2025-03-06
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2004-06-16
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2025-06-18

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
3004672275	INOGEN, INC.	Goleta, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019385742. Last updated year: 2026. Please use registration number 3019385742 when referencing this establishment in official correspondence.