Inogen, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Inogen, Inc.” (first 2004, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 245 days. Since 2017 the median was 175 days, against 224 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 316 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 147 |
| 2023 | 1 | 175 |
| 2024 | 1 | 245 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inogen, Inc. took a median 175 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 224 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 4 | 4 |
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Inogen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241091 | SIMEOX 200 Airway Clearance Device | SDT | 2024-12-23 | 245 |
| K230052 | Inogen Rove 6 | CAW | 2023-06-30 | 175 |
| K222086 | Inogen Rove 4 Portable Oxygen Concentrator | CAW | 2022-12-09 | 147 |
| K132489 | INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) | CAW | 2014-06-20 | 316 |
| K032818 | INOGEN ONE OXYGEN CONCENTRATOR | CAW | 2004-05-13 | 246 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-08-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Inogen, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06555484: Acute Effects of Supplemental Oxygen on Memory Testing in Healthy Adult Volunteers (Completed, started 2024-05-28)
- NCT06000332: Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia (Completed, started 2023-10-17)
- NCT05719363: Portable Oxygen Concentrator in Non-hospitalized Patients With Chronic Heart Failure (Completed, started 2023-10-11)
- NCT05212831: Portable Oxygen Concentrator (POC) Versus Standard of Care in Long-COVID: Randomized Crossover Exploratory Pilot Study. (Completed, started 2022-06-08)
SEC filings
Inogen Inc (INGN): EDGAR filings, CIK 1294133. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Inogen, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Inogen, Inc.” (first 2004, latest 2024), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Inogen, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inogen, Inc. is 245 days. Since 2017: 175 days, versus 224 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inogen, Inc.?
The most frequent FDA product codes under this applicant name are CAW (Generator, Oxygen, Portable, 4); SDT (Intra-Pulmonary Percussive Vibration (Ipv) Devices, 1).
Next steps
- See all 5 Inogen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAW, Inogen, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.