Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nihon Kohden Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
224 daysmedian FDA review time
762 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130238 | NIHON KOHDEN AE-918P NEURO UNIT | Nihon Kohden Corp. | 2015-03-04 | 762 | 0 |
| K122214 | TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) | Nihon Kohden Corp. | 2013-05-21 | 300 | 0 |
| K120888 | PSG-1100 SLEEP DIAGNOSTIC SYSTEM | Nihon Kohden Corp. | 2012-11-09 | 231 | 1 |
| K120397 | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTE | Nihon Kohden Corp. | 2012-09-19 | 224 | 0 |
| K110594 | GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS | Nihon Kohden Corp. | 2011-10-28 | 240 | 0 |
| K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | Nihon Kohden Corp. | 2011-08-04 | 171 | 0 |
| K110376 | PE-210AK SWITCH BOX | Nihon Kohden Corp. | 2011-07-29 | 170 | 0 |
| K102106 | NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION | Nihon Kohden Corp. | 2010-12-17 | 143 | 0 |
| K102376 | NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CN | Nihon Kohden Corp. | 2010-12-07 | 109 | 1 |
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