Data / Medical devices / United States / Inogen, Inc
Inogen, Inc: FDA-registered device maker in Plano, TX, United States, 6 510(k) clearances
Inogen, Inc is registered with the FDA (registration 3019385742) in Plano, TX, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3019385742
- FEI number
- 3009843463
- Address
- 600 Shiloh Rd., Plano, TX, United States, 75074
- Owner or operator
- INOGEN, INC. (9064201)
- Roles
- Manufacturer, Remanufacturer, Repackager or relabeler
- 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 | Manufacturer | accessdata.fda.gov |
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | 2 | Manufacturer, Remanufacturer, Repackager or relabeler | 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 |
| 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 |
| 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 |
Compare with other makers
- All makers of Intra-Pulmonary Percussive Vibration (Ipv) Devices
- All makers of Generator, Oxygen, Portable
- All makers of Ventilator, Non-Continuous (Respirator)
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.