Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nihon Kohden Orangemed, 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) |
|---|---|---|---|---|---|
| K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | 2023-05-31 | 272 | 0 |
| K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022-07-01 | 240 | 0 |
| K192307 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2020-01-10 | 137 | 0 |
| K181695 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2018-12-07 | 163 | 0 |
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