# Nihon Kohden America, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 166 (1979–2012): 166 510(k) clearances
- Product codes: DPS (21), DSI (18), GWQ (15), MHX (11), DRT (10), OLV (9), CCK (9), LDD (8), GWF (7), DQA (6), DRG (5), LOS (4)
- Predicates its devices cite: 62 (47 its own); citations of its devices by later devices: 99 (47 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hewlett-Packard Co.: 1 (https://510kreport.com/company/hewlett-packard)
- Nellcor, Inc.: 1 (https://510kreport.com/company/nellcor)
- Compumedics Limited: 1 (https://510kreport.com/company/compumedics)
- Bio-Logic Systems Corp.: 1 (https://510kreport.com/company/bio-logic-systems)
- Oxford Instruments, Plc.: 1 (https://510kreport.com/company/oxford-instruments)
- Quinton, Inc.: 1 (https://510kreport.com/company/quinton)
- Applied Neuroscience, Inc.: 1 (https://510kreport.com/company/applied-neuroscience)
- Brainscope Company, Inc.: 1 (https://510kreport.com/company/brainscope)

## Firms that cite its devices most
- Nihon Kohden Corporation: 27 (https://510kreport.com/company/nihon-kohden)
- Anybattery, Inc.: 3 (https://510kreport.com/company/anybattery)
- Neurotronics, Inc.: 3 (https://510kreport.com/company/neurotronics)
- Carefusion 209, Inc.: 2 (https://510kreport.com/company/carefusion-209)
- Fukuda Denshi USA, Inc.: 2 (https://510kreport.com/company/fukuda-denshi-usa)
- Carefusion 303, Inc.: 1 (https://510kreport.com/company/carefusion-303)
- Tapuz Medical Technology, Ltd.: 1 (https://510kreport.com/company/tapuz-medical-technology)
- Pascall Systems, Inc.: 1 (https://510kreport.com/company/pascall-systems)

## Its most-cited devices
- K011918: Nihon  Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A Series (2001), cited by 5
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series (2008), cited by 5
- K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A (2008), cited by 5
- K914092: BSM-2100A Configured Patient Monitor (1992), cited by 4
- K040875: Cap-One, Model TG-920P (2004), cited by 3
- K043517: Transmitter, ZS-940PA Series (2005), cited by 3

## Recent decisions
- K113117: Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box (Mar 22, 2012)
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (Mar 16, 2012)
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (Jul 9, 2010)
- K083456: Nihon Kohden CO2 Sensor Kit, Model TG-970P (Mar 2, 2009)
- K083271: BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series Optional Accessory (Dec 24, 2008)
- K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series (Nov 26, 2008)
- K071969: Sen-4100 Electric Stimulator (Oct 6, 2008)
- K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A (Aug 29, 2008)

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