Nihon Kohden Corporation: FDA clearances and approvals
Nihon Kohden Corporation has 31 FDA 510(k) clearances (first 2010, latest 2026), across 15 product codes in 3 review panels. Median 510(k) review time: 171 days. Since 2017 its median was 147 days, against 183 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 12 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 228 |
| 2013 | 1 | 300 |
| 2014 | 0 | — |
| 2015 | 3 | 220 |
| 2016 | 2 | 246 |
| 2017 | 5 | 130 |
| 2018 | 0 | — |
| 2019 | 2 | 90 |
| 2020 | 1 | 198 |
| 2021 | 3 | 235 |
| 2022 | 1 | 108 |
| 2023 | 1 | 244 |
| 2024 | 0 | — |
| 2025 | 2 | 165 |
| 2026 | 2 | 250 |
Review time against the same product codes
Since 2017, Nihon Kohden Corporation's cleared 510(k)s took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 | 6 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 6 | 6 |
| GWQ | Full-Montage Standard Electroencephalograph | 3 | 3 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 3 | 3 |
| GWF | Stimulator, Electrical, Evoked Response | 2 | 2 |
| OMA | Amplitude-Integrated Electroencephalograph | 2 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| GYB | Media, Electroconductive | 1 | 1 |
Plus 5 more product codes.
Review panels
- Cardiovascular (11)
- Neurology (11)
- Anesthesiology (9)
Most recent Nihon Kohden Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R) | CCK | 2026-08-12 | 440 |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | DXQ | 2026-05-06 | 61 |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | OLT | 2025-10-09 | 161 |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | CCK | 2025-06-10 | 169 |
| K223567 | CNS-2101 Central Monitor | MSX | 2023-07-31 | 244 |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | KOI | 2022-07-21 | 108 |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM | KOI | 2021-12-29 | 86 |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System | MHX | 2021-07-16 | 235 |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | KOI | 2021-05-02 | 293 |
| K191975 | Elefix V Paste for EEG & EMG | GYB | 2020-02-07 | 198 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nihon Kohden Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Nihon Kohden Corporation is the industry lead sponsor of 12 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT07408388: Pulse Oximeter Accuracy During Stable Hypoxia Plateaus (Active not recruiting, started 2025-12-03)
- NCT07168798: SpO2 Accuracy in Children (Enrolling by invitation, started 2025-11-12)
- NCT06689215: Comparison of Noninvasive vs. Invasive Hemodynamic Measurements (Active not recruiting, started 2024-10-21)
- NCT05807477: Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO19) (Completed, started 2023-04-18)
- NCT05807464: Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18) (Completed, started 2023-04-12)
Frequently asked questions
How many FDA 510(k) clearances does Nihon Kohden Corporation have?
Nihon Kohden Corporation has 31 FDA 510(k) clearances (first 2010, latest 2026), across 15 product codes in 3 review panels.
How long does FDA take to clear Nihon Kohden Corporation's 510(k)s?
The median time from FDA receipt to decision across Nihon Kohden Corporation's cleared 510(k)s is 171 days. Since 2017: 147 days, versus 183 days for all cleared 510(k)s in the same product codes.
What devices does Nihon Kohden Corporation make?
Its most frequent FDA product codes are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 6); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 6); GWQ (Full-Montage Standard Electroencephalograph, 3).
Has Nihon Kohden Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Nihon Kohden Corporation. Related entities may recall under other names.
Next steps
- See all 31 Nihon Kohden Corporation clearances with predicates and recalls
- Run predicate analysis for product code CCK, Nihon Kohden Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.