Nihon Kohden Orangemed, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nihon Kohden Orangemed, Inc.” (first 2018, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 240 days. Since 2017 the median was 240 days, against 265 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 |
|---|---|---|
| 2018 | 1 | 163 |
| 2019 | 0 | — |
| 2020 | 1 | 137 |
| 2021 | 0 | — |
| 2022 | 1 | 240 |
| 2023 | 1 | 272 |
| 2024 | 1 | 259 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nihon Kohden Orangemed, Inc. took a median 240 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 265 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 4 | 4 |
| MNT | Sv70 Ventilator | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Nihon Kohden Orangemed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | CBK | 2024-03-01 | 259 |
| K222644 | Nihon Kohden NKV-440 Ventilator System | CBK | 2023-05-31 | 272 |
| K213521 | Nihon Kohden NKV-330 Ventilator System | MNT | 2022-07-01 | 240 |
| K192307 | Nihon Kohden NKV-550 Series Ventilator System | CBK | 2020-01-10 | 137 |
| K181695 | Nihon Kohden NKV-550 Series Ventilator System | CBK | 2018-12-07 | 163 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-07-20.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nihon Kohden America, Inc. (166 510(k)s)
- Nihon Kohden Corporation (31 510(k)s)
- Nihon Seimitsu Sokki Co., Ltd. (21 510(k)s)
- Nihon Kohden Digital Health Solutions, LLC (2 510(k)s)
- Nihon Medix Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nihon Kohden Orangemed, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nihon Kohden Orangemed, Inc.” (first 2018, 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 Nihon Kohden Orangemed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nihon Kohden Orangemed, Inc. is 240 days. Since 2017: 240 days, versus 265 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nihon Kohden Orangemed, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 4); MNT (Sv70 Ventilator, 1).
Next steps
- See all 5 Nihon Kohden Orangemed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Nihon Kohden Orangemed, 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.