Data / Medical devices / United States / Nihon Kohden America, Inc.
Nihon Kohden America, Inc.: FDA-registered device maker in Irvine, CA, United States, 52 510(k) clearances
Nihon Kohden America, Inc. is registered with the FDA (registration 2080783) in Irvine, CA, United States. It lists 49 device types. The FDA files 52 510(k) clearances under its listings, the newest dated October 9, 2025. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2080783
- Address
- 15353 Barranca Pkwy, Irvine, CA, United States, 92618
- Owner or operator
- NIHON KOHDEN CORP. (8030227)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- October 31, 2007
- Registered through
- 2026
- Brand names listed
- A/326391 Cable, A/646225 Cable, A/ABC300-11MED, A/AIRPHOTICKIT, A/CE620NK, A/DCIN1200, A/EJ110-0010 Cable, A/FQW-50-2-100 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2025 | K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | OLT | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| June 10, 2025 | K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | CCK | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| July 31, 2023 | K223567 | CNS-2101 Central Monitor | MSX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| July 21, 2022 | K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | KOI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| December 29, 2021 | 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 | KOI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| July 16, 2021 | K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System | MHX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| May 2, 2021 | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | KOI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| February 7, 2020 | K191975 | Elefix V Paste for EEG & EMG | GYB | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| March 19, 2019 | K183529 | AE-120A EEG Head Set | OMC | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| October 11, 2017 | K171765 | Nihon Kohden CO2 Monitor | CCK | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| August 25, 2017 | K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | GWQ | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| May 19, 2017 | K163644 | Nihon Kohden QP-160AK EEG Trend Program | OMA | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| April 4, 2017 | K163459 | Nihon Kohden Vital Sign Telemeter | MHX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| February 24, 2017 | K161860 | TG-970P CO2 Sensor Kit | CCK | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| September 2, 2016 | K153707 | Nihon Kohden Vital Sign Telemeter | MHX | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| April 8, 2016 | K152305 | Nihon Kohden Afib Detection Program QP-039P | DSI | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| November 5, 2015 | K151080 | Nihon Kohden CSM 1901 Bedside Monitor | MHX | Substantially Equivalent | Nihon Kohden | accessdata.fda.gov |
| April 24, 2015 | K142624 | Neuromaster G1 MEE200 | GWF | Substantially Equivalent | Nihon Kohden Corporation | accessdata.fda.gov |
| March 4, 2015 | K130238 | NIHON KOHDEN AE-918P NEURO UNIT | OMA | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| May 21, 2013 | K122214 | TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) | CCK | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| November 9, 2012 | K120888 | PSG-1100 SLEEP DIAGNOSTIC SYSTEM | GWQ | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| September 19, 2012 | K120397 | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM | GWF | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| March 22, 2012 | K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX | GWQ | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| March 16, 2012 | K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | OMA | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 28, 2011 | K110594 | GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS | CCK | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| August 4, 2011 | K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | GYC | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| July 29, 2011 | K110376 | PE-210AK SWITCH BOX | GWQ | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| December 7, 2010 | K102376 | NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 | MHX | Substantially Equivalent | Nihon Kohden Corp. | accessdata.fda.gov |
| March 2, 2009 | K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 6, 2008 | K071969 | SEN-4100 ELECTRIC STIMULATOR | GWF | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| August 29, 2008 | K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | OLT | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| February 26, 2008 | K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES | MHX | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| January 11, 2008 | K073491 | EEG-1100A SWITCH BOX | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| November 29, 2007 | K072843 | YG-125T AND YG-135T NASAL ADAPTER | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| August 30, 2007 | K072217 | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M | DPS | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| June 29, 2007 | K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A | DRG | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| December 27, 2006 | K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| August 17, 2005 | K051178 | MEE-1000A NEUROMASTER | GWF | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| April 29, 2005 | K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| February 3, 2005 | K043517 | TRANSMITTER, ZS-940PA SERIES | DRT | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 15, 2004 | K040875 | CAP-ONE, MODEL TG-920P | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| September 16, 2003 | K032749 | BEDSIDE MONITOR, MODEL OPV-1500 | MWI | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| July 29, 2002 | K022121 | PSG INPUT BOX, MODEL JE-912AK | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| July 25, 2002 | K020046 | MULTIGAS UNIT, MODEL AG-920RA | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| September 12, 2001 | K011918 | NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES | MHX | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| June 28, 2001 | K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES | IKN | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| May 8, 2001 | K011204 | NEUROFAX, MODELS EEG-1100A, EEG-9100A | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| October 14, 1999 | K992742 | NEUROFAX, MODEL EEG-1100A | OLV | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| June 9, 1999 | K990063 | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES | CCK | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| March 13, 1987 | K870795 | EMG ELECTRODES AND EXTENSION CORDS | IKT | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| November 13, 1986 | K862799 | SKIN PURE | GYB | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
| July 1, 1986 | K860210 | ELEFIX ELECTRODE CREAM | GYB | Substantially Equivalent | Nihon Kohden America, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | 99549 | Class II | Ongoing | Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Description: The device is | Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms. | accessdata.fda.gov |
| September 18, 2024 | 95426 | Class II | Ongoing | Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | accessdata.fda.gov |
| April 29, 2024 | 94472 | Class II | Ongoing | BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a | Due to software issue the device may give false "SpO2 Probe Failure" alarm | accessdata.fda.gov |
| April 29, 2022 | 95480 | Class II | Ongoing | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intende | Due to products being shipped/distributed to customers after the products expiration date had past. | accessdata.fda.gov |
| January 8, 2021 | 87264 | Class II | Ongoing | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. | accessdata.fda.gov |
| December 21, 2020 | 87011 | Class II | Ongoing | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier in | Medical device non-conformance to electrical safety standard (IEC 60601-1). | accessdata.fda.gov |
| March 13, 2017 | 76723 | Class II | Terminated | Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA). | The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. | accessdata.fda.gov |
| April 14, 2015 | 71015 | Class II | Terminated | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound. | accessdata.fda.gov |
| June 3, 2014 | 68459 | Class II | Terminated | CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients. | Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate. | accessdata.fda.gov |
| January 19, 2012 | 73114 | Class II | Terminated | MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG) | The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow. | accessdata.fda.gov |
| August 23, 2006 | 36394 | Not yet classified | Terminated | Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System) | When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time. | accessdata.fda.gov |
| December 5, 2003 | 28025 | Not yet classified | Terminated | AG-920RA Multi-gas unit analyzer | Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough. | accessdata.fda.gov |
Compare with other makers
- All makers of Headlamp, Operating, Battery-Operated
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Probe, Ent
Updated October 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.