Nihon Seimitsu Sokki Co., Ltd.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Nihon Seimitsu Sokki Co., Ltd.” (first 1985, latest 2012), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 106 days. 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 | 3 | 162 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 18 | 18 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
| MNW | Analyzer, Body Composition | 1 | 1 |
Review panels
Most recent Nihon Seimitsu Sokki Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112620 | DISITAL BLOOD PRESSURE MONITOR | DXN | 2012-08-02 | 329 |
| K112691 | BLOOD PRESSURE MONITOR | DXN | 2012-02-24 | 162 |
| K112690 | BLOOD PRESSURE MONITOR | DXN | 2012-02-24 | 162 |
| K093102 | AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 | DXN | 2010-06-03 | 245 |
| K080177 | WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV | DXN | 2008-05-09 | 106 |
| K071596 | POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 | IRP | 2008-02-15 | 248 |
| K071384 | MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 | DXN | 2007-10-09 | 145 |
| K061086 | DM-3000 DIGITAL BLOOD PRESSURE MONITOR | DXN | 2006-08-10 | 114 |
| K050697 | MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR | DXN | 2005-03-25 | 7 |
| K040309 | DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 | DXN | 2004-02-24 | 15 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nihon Seimitsu Sokki Co., Ltd..
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 Kohden Orangemed, Inc. (5 510(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 Seimitsu Sokki Co., Ltd.?
FDA lists 21 510(k) clearances under the applicant name “Nihon Seimitsu Sokki Co., Ltd.” (first 1985, latest 2012), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nihon Seimitsu Sokki Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nihon Seimitsu Sokki Co., Ltd. is 106 days.
Which FDA product codes appear under Nihon Seimitsu Sokki Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 18); DXQ (Blood Pressure Cuff, 1); IRP (Massager, Powered Inflatable Tube, 1).
Next steps
- See all 21 Nihon Seimitsu Sokki Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Nihon Seimitsu Sokki Co., Ltd.'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.