Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inogen, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241091 | SIMEOX 200 Airway Clearance Device | Inogen, Inc. | 2024-12-23 | 245 | 0 |
| K230052 | Inogen Rove 6 | Inogen, Inc. | 2023-06-30 | 175 | 0 |
| K132489 | INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) | Inogen, Inc. | 2014-06-20 | 316 | 0 |
| K032818 | INOGEN ONE OXYGEN CONCENTRATOR | Inogen, Inc. | 2004-05-13 | 246 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda