Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nihon Kohden America, Inc. · Predicate Candidate Screening
166 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
259 days90th percentile
166clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE | Nihon Kohden America, Inc. | 2012-03-22 | 153 | 0 |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DS | Nihon Kohden America, Inc. | 2012-03-16 | 28 | 0 |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | Nihon Kohden America, Inc. | 2010-07-09 | 323 | 0 |
| K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | Nihon Kohden America, Inc. | 2009-03-02 | 101 | 0 |
| K083271 | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY | Nihon Kohden America, Inc. | 2008-12-24 | 48 | 0 |
| K082785 | NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES | Nihon Kohden America, Inc. | 2008-11-26 | 64 | 0 |
| K071969 | SEN-4100 ELECTRIC STIMULATOR | Nihon Kohden America, Inc. | 2008-10-06 | 447 | 0 |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | Nihon Kohden America, Inc. | 2008-08-29 | 183 | 0 |
| K073550 | PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION | Nihon Kohden America, Inc. | 2008-03-28 | 101 | 0 |
| K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES | Nihon Kohden America, Inc. | 2008-02-26 | 18 | 0 |
| K073491 | EEG-1100A SWITCH BOX | Nihon Kohden America, Inc. | 2008-01-11 | 30 | 0 |
| K072843 | YG-125T AND YG-135T NASAL ADAPTER | Nihon Kohden America, Inc. | 2007-11-29 | 56 | 0 |
| K072217 | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX | Nihon Kohden America, Inc. | 2007-08-30 | 21 | 0 |
| K072060 | QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CA | Nihon Kohden America, Inc. | 2007-08-17 | 21 | 0 |
| K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A | Nihon Kohden America, Inc. | 2007-06-29 | 74 | 0 |
| K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | Nihon Kohden America, Inc. | 2006-12-27 | 156 | 0 |
| K052511 | CARDIOFAX CE, MODEL ECG-1500 A | Nihon Kohden America, Inc. | 2006-05-24 | 252 | 0 |
| K051178 | MEE-1000A NEUROMASTER | Nihon Kohden America, Inc. | 2005-08-17 | 100 | 1 |
| K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A | Nihon Kohden America, Inc. | 2005-04-29 | 28 | 0 |
| K043517 | TRANSMITTER, ZS-940PA SERIES | Nihon Kohden America, Inc. | 2005-02-03 | 45 | 0 |
| K042827 | CARDIOFAX CE, MODEL PEA-1110K | Nihon Kohden America, Inc. | 2005-01-06 | 86 | 0 |
| K040875 | CAP-ONE, MODEL TG-920P | Nihon Kohden America, Inc. | 2004-10-15 | 196 | 0 |
| K040395 | CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES | Nihon Kohden America, Inc. | 2004-06-01 | 105 | 0 |
| K033475 | WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES | Nihon Kohden America, Inc. | 2004-01-07 | 65 | 0 |
| K032749 | BEDSIDE MONITOR, MODEL OPV-1500 | Nihon Kohden America, Inc. | 2003-09-16 | 11 | 0 |
| K030105 | ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A | Nihon Kohden America, Inc. | 2003-03-04 | 50 | 0 |
| K023475 | CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES | Nihon Kohden America, Inc. | 2002-10-24 | 8 | 1 |
| K022121 | PSG INPUT BOX, MODEL JE-912AK | Nihon Kohden America, Inc. | 2002-07-29 | 28 | 0 |
| K020046 | MULTIGAS UNIT, MODEL AG-920RA | Nihon Kohden America, Inc. | 2002-07-25 | 199 | 0 |
| K011918 | NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIE | Nihon Kohden America, Inc. | 2001-09-12 | 84 | 0 |
| K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES | Nihon Kohden America, Inc. | 2001-06-28 | 121 | 0 |
| K011204 | NEUROFAX, MODELS EEG-1100A, EEG-9100A | Nihon Kohden America, Inc. | 2001-05-08 | 19 | 0 |
| K002068 | ORG-9200A | Nihon Kohden America, Inc. | 2001-02-08 | 216 | 0 |
| K002473 | WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES | Nihon Kohden America, Inc. | 2000-11-08 | 89 | 0 |
| K001433 | CNS-9300 SERIES CENTRAL STATION | Nihon Kohden America, Inc. | 2000-11-07 | 183 | 0 |
| K001693 | LIFE SCOPE P, MODEL BSM-4100 SERIES | Nihon Kohden America, Inc. | 2000-10-24 | 144 | 0 |
| K000517 | LIFE SCOPE EC, MODEL BSM-1102 | Nihon Kohden America, Inc. | 2000-08-31 | 197 | 0 |
| K000338 | VITAPORT 3 | Nihon Kohden America, Inc. | 2000-04-26 | 83 | 0 |
| K992455 | NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES | Nihon Kohden America, Inc. | 2000-01-07 | 168 | 0 |
| K992742 | NEUROFAX, MODEL EEG-1100A | Nihon Kohden America, Inc. | 1999-10-14 | 59 | 0 |
| K991899 | NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEAS | Nihon Kohden America, Inc. | 1999-09-01 | 89 | 1 |
| K990063 | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES | Nihon Kohden America, Inc. | 1999-06-09 | 152 | 0 |
| K990031 | NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCES | Nihon Kohden America, Inc. | 1999-04-16 | 101 | 0 |
| K984504 | NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSO | Nihon Kohden America, Inc. | 1999-04-15 | 118 | 0 |
| K983072 | AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR32 | Nihon Kohden America, Inc. | 1998-12-01 | 90 | 0 |
| K974292 | NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND AC | Nihon Kohden America, Inc. | 1998-06-08 | 206 | 0 |
| K973918 | NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCES | Nihon Kohden America, Inc. | 1998-01-13 | 90 | 0 |
| K971436 | NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRI | Nihon Kohden America, Inc. | 1997-10-21 | 186 | 0 |
| K972310 | NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON | Nihon Kohden America, Inc. | 1997-08-20 | 61 | 0 |
| K971355 | NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND | Nihon Kohden America, Inc. | 1997-07-15 | 95 | 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