# Nihon Kohden Corporation

- Location (FDA's records): Tokyo, JP
- FDA decisions: 31 (2010–2026): 31 510(k) clearances
- Names in FDA's records: Nihon Kohden Corporation (20); Nihon Kohden Corp. (9); Nihon Kohden (2)
- Product codes: CCK (6), MHX (6), GWQ (3), KOI (3), OMA (2), GWF (2), GYB (1), GYC (1), DRG (1), MSX (1), OMC (1), MWI (1)
- 510(k) review time since 2016: median 184 days, against 178 for FDA's reviews in the same codes and years (6 of 14 faster)
- Predicates its devices cite: 55 (7 its own); citations of its devices by later devices: 18 (7 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nihon Kohden America, Inc.: 27 (https://510kreport.com/company/nihon-kohden-america)
- Ceribell, Inc.: 2 (https://510kreport.com/company/ceribell)
- Persyst Development Corporation: 1 (https://510kreport.com/company/persyst-development)
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)
- Radionics, Inc.: 1 (https://510kreport.com/company/radionics)
- Meps, LLC: 1 (https://510kreport.com/company/meps)
- Axon Systems, Inc.: 1 (https://510kreport.com/company/axon-systems)
- Draeger Medical Systems, Inc.: 1 (https://510kreport.com/company/draeger-medical-systems)

## Firms that cite its devices most
- Neurotronics, Inc.: 2 (https://510kreport.com/company/neurotronics)
- Nihon Kohden Digital Health Solutions, LLC: 2 (https://510kreport.com/company/nihon-kohden-digital-health-solutions)
- Neba Health, LLC: 1 (https://510kreport.com/company/neba-health)
- Cadwell Industries, Inc.: 1 (https://510kreport.com/company/cadwell-industries)
- Blinktbi, Inc.: 1 (https://510kreport.com/company/blinktbi)
- Bioserenity Sas: 1 (https://510kreport.com/company/bioserenity)
- Blackrock Neuromed: 1 (https://510kreport.com/company/blackrock-neuromed)
- Epitel, Inc.: 1 (https://510kreport.com/company/epitel)

## Its most-cited devices
- K183529: AE-120A EEG Head Set (2019), cited by 3
- K110410: MS-120BK Electric Stimulator (Extension Unit) (2011), cited by 2
- K120888: PSG-1100 Sleep Diagnostic System (2012), cited by 2
- K201949: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (2021), cited by 2
- K110594: GF-210R Multi-Gas Module for Nohon Kohden Bedside Monitors (2011), cited by 1
- K151080: Nihon Kohden CSM 1901 Bedside Monitor (2015), cited by 1

## Recent decisions
- K251641: GF-310R Multigas Unit (GF-310R) (Aug 12, 2026)
- K260747: YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff (May 6, 2026)
- K251366: EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) (Oct 9, 2025)
- K243956: TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (Jun 10, 2025)
- K223567: CNS-2101 Central Monitor (Jul 31, 2023)
- K220976: Life Scope PT BSM-1700 Series Bedside Monitor (Jul 21, 2022)
- 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 (Dec 29, 2021)
- K203435: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System (Jul 16, 2021)

Source page: https://510kreport.com/company/nihon-kohden