FDA.reportPublic FDA data

Inogen, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30193857423009843463Inogen, Inc1Y2026-01-01600 Shiloh Rd. Plano TX US 75074
30152382043015238204Inogen, Inc1Y2020-04-251225 Commerce Drive Richardson TX US 75081
30152586483015258648Inogen, Inc1N2020-04-251 American Road Suite #650 Brooklyn OH US 44144

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2935461398836742K241091SIMEOX 200 Airway Clearance DeviceSDT2024-12-23
2935461605858867K230052Inogen Rove 6CAW2023-06-30
2935461777611088K222086Inogen Rove 4 Portable Oxygen ConcentratorCAW2022-12-09
2935461436153410K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskBZD2021-07-02
2258161517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
2265291517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
2935461517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
2258161180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13
2265291180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13
2935461180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAW82023-06-30
SDT12024-12-23
BZD12021-07-02