Company ยท US
Inogen, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2024. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2024 | K241091 | SIMEOX 200 Airway Clearance Device Inogen, Inc. | SDT |
| Jun 30, 2023 | K230052 | Inogen Rove 6 Inogen, Inc. | CAW |
| Dec 9, 2022 | K222086 | Inogen Rove 4 Portable Oxygen Concentrator Inogen | CAW |
| Jun 20, 2014 | K132489 | INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) Inogen, Inc. | CAW |
| May 13, 2004 | K032818 | INOGEN ONE OXYGEN CONCENTRATOR Inogen, Inc. | CAW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2005 | Inogen, Inc Portable Oxygen Generator Terminated |
CAW | K032818 |