Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nihon Kohden Corporation · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
254 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | 2026-05-06 | 61 | 0 |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier | Nihon Kohden Corporation | 2025-10-09 | 161 | 0 |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (T | Nihon Kohden Corporation | 2025-06-10 | 169 | 0 |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023-07-31 | 244 | 0 |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | 2022-07-21 | 108 | 0 |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition U | Nihon Kohden Corporation | 2021-12-29 | 86 | 0 |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon | Nihon Kohden Corporation | 2021-07-16 | 235 | 0 |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 | Nihon Kohden Corporation | 2021-05-02 | 293 | 0 |
| K191975 | Elefix V Paste for EEG & EMG | Nihon Kohden Corporation | 2020-02-07 | 198 | 0 |
| K190468 | Nihon Kohden SVM-7200 Series Vital Signs Monitor | Nihon Kohden Corporation | 2019-05-28 | 91 | 0 |
| K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019-03-19 | 90 | 0 |
| K171765 | Nihon Kohden CO2 Monitor | Nihon Kohden Corporation | 2017-10-11 | 119 | 1 |
| K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | Nihon Kohden Corporation | 2017-08-25 | 130 | 0 |
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | 2017-05-19 | 147 | 0 |
| K163459 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corporation | 2017-04-04 | 116 | 0 |
| K161860 | TG-970P CO2 Sensor Kit | Nihon Kohden Corporation | 2017-02-24 | 233 | 0 |
| K153707 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corporation | 2016-09-02 | 254 | 0 |
| K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | 2016-04-08 | 238 | 0 |
| K142624 | Neuromaster G1 MEE200 | Nihon Kohden Corporation | 2015-04-24 | 220 | 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