Data / Medical devices / United States / Inogen, Inc.
Inogen, Inc.: FDA-registered device maker in Goleta, CA, United States, 8 510(k) clearances
Inogen, Inc. is registered with the FDA (registration 3004672275) in Goleta, CA, United States. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 23, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004672275
- Address
- 859 Ward Drive Suite 200, Goleta, CA, United States, 93111
- Owner or operator
- INOGEN, INC. (9064201)
- Roles
- Complaint file establishment, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 16, 2004
- Registered through
- 2026
- Brand names listed
- Aurora, INOGEN ONE G2 OXYGEN CONCENTRATOR, INOGEN ONE G3 OXYGEN CONCENTRATOR, INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR, INOGEN ONE G4 OXYGEN CONCENTRATOR, INOGEN ONE G5 OXYGEN CONCENTRATOR, INOGEN ONE OXYGEN CONCENTRATOR, Inogen At Home GS 100 Oxygen Concentrator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mechanical Ventilator | ONZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2024 | K241091 | SIMEOX 200 Airway Clearance Device | SDT | Substantially Equivalent | Inogen, Inc. | accessdata.fda.gov |
| June 30, 2023 | K230052 | Inogen Rove 6 | CAW | Substantially Equivalent | Inogen, Inc. | accessdata.fda.gov |
| April 28, 2023 | K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | CAW | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| December 9, 2022 | K222086 | Inogen Rove 4 Portable Oxygen Concentrator | CAW | Substantially Equivalent | Inogen | accessdata.fda.gov |
| July 2, 2021 | K203347 | Sleep 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 Mask | BZD | Substantially Equivalent | Suzhou Yuyue Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 2, 2016 | K152664 | TAV System | ONZ | Substantially Equivalent | New Aera, Inc. | accessdata.fda.gov |
| June 20, 2014 | K132489 | INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) | CAW | Substantially Equivalent | Inogen, Inc. | accessdata.fda.gov |
| May 13, 2004 | K032818 | INOGEN ONE OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Inogen, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 1, 2005 | 32735 | Not yet classified | Terminated | Portable Oxygen Generator | Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Intra-Pulmonary Percussive Vibration (Ipv) Devices
Updated December 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.