Inogen Rove 6
FDA 510(k) K230052 · Inogen, Inc.
510(k) numberK230052
Submission
- Device name
- Inogen Rove 6
- Applicant
- Inogen, Inc.
Goleta, CA, US - Received
- January 6, 2023
- Decision date
- June 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
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| K252965 | Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional | Oxytek Medical Technology Co., Ltd. | 05/29/2026SE |
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| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | Devilbiss Healthcare, LLC | 03/26/2026SE |
| K251534 | Oxygen Concentrator (J10A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 12/29/2025SE |
| K252616 | Portable oxygen concentrator (JLO-190P)CAW · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 12/22/2025SE |
| K251764 | Oxygen Concentrator-P2-O5ECAW · Traditional | Qingdao Kingon Medical Science and Technology… | 12/22/2025SE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional | Shenzhen Harveymed Technology Co., Ltd. | 12/16/2025SE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
More from Devilbiss Healthcare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K241091 | SIMEOX 200 Airway Clearance DeviceSDT · Traditional | 12/23/2024SE |
| K222086 | Inogen Rove 4 Portable Oxygen ConcentratorCAW · Traditional | 12/09/2022SE |
| K132489 | Inogen at Home Oxygen Concentrator (Aka Inogen at Home)CAW · Traditional | 06/20/2014SE |
| K032818 | Inogen One Oxygen ConcentratorCAW · Traditional | 05/13/2004SE |
Questions and answers
When was Inogen Rove 6 cleared by the FDA?
Inogen Rove 6 (K230052) received a 510(k) decision of Substantially Equivalent on June 30, 2023, 175 days after the submission was received.
What is the product code of K230052?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.