K222086 is an FDA 510(k) clearance for the Inogen Rove 4 Portable Oxygen Concentrator. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Inogen (Goleta, US). The FDA issued a Cleared decision on December 9, 2022, 147 days after receiving the submission on July 15, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K222086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2022 |
| Decision Date | December 09, 2022 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW - Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |