Nihon Kohden America Inc
Irvine, CA, US
NIHON KOHDEN AMERICA, INC. appears in FDA device records in Irvine, CA. FDA records list 166 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 166FDA records hold 166 510(k) clearances for Nihon Kohden America Inc between 1979 and 2012. The busiest year on record is 1986, with 17. The most recent is 2012, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 6 |
| 1980 | 6 |
| 1981 | 3 |
| 1982 | 8 |
| 1983 | 5 |
| 1984 | 12 |
| 1985 | 4 |
| 1986 | 17 |
| 1987 | 8 |
| 1988 | 9 |
| 1989 | 8 |
| 1990 | 6 |
| 1991 | 6 |
| 1992 | 6 |
| 1994 | 2 |
| 1995 | 7 |
| 1996 | 1 |
| 1997 | 5 |
| 1998 | 3 |
| 1999 | 5 |
| 2000 | 6 |
| 2001 | 4 |
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 7 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX | GWQ | Substantially Equivalent | |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | OMA | Substantially Equivalent | |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | OMA | Substantially Equivalent | |
| K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | CCK | Substantially Equivalent | |
| K083271 | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY | MHX | Substantially Equivalent | |
| K082785 | NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES | MHX | Substantially Equivalent | |
| K071969 | SEN-4100 ELECTRIC STIMULATOR | GWF | Substantially Equivalent | |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | OLT | Substantially Equivalent | |
| K073550 | PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION | MHX | Substantially Equivalent | |
| K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES | MHX | Substantially Equivalent | |
| K073491 | EEG-1100A SWITCH BOX | OLV | Substantially Equivalent | |
| K072843 | YG-125T AND YG-135T NASAL ADAPTER | CCK | Substantially Equivalent | |
| K072217 | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M | DPS | Substantially Equivalent | |
| K072060 | QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V | DPS | Substantially Equivalent | |
| K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A | DRG | Substantially Equivalent | |
| K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | CCK | Substantially Equivalent | |
| K052511 | CARDIOFAX CE, MODEL ECG-1500 A | DPS | Substantially Equivalent | |
| K051178 | MEE-1000A NEUROMASTER | GWF | Substantially Equivalent | |
| K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A | OLV | Substantially Equivalent | |
| K043517 | TRANSMITTER, ZS-940PA SERIES | DRT | Substantially Equivalent | |
| K042827 | CARDIOFAX CE, MODEL PEA-1110K | DPS | Substantially Equivalent | |
| K040875 | CAP-ONE, MODEL TG-920P | CCK | Substantially Equivalent | |
| K040395 | CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES | MHX | Substantially Equivalent | |
| K033475 | WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES | OLV | Substantially Equivalent | |
| K032749 | BEDSIDE MONITOR, MODEL OPV-1500 | MWI | Substantially Equivalent | |
| K030105 | ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A | MHX | Substantially Equivalent | |
| K023475 | CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES | MHX | Substantially Equivalent | |
| K022121 | PSG INPUT BOX, MODEL JE-912AK | OLV | Substantially Equivalent | |
| K020046 | MULTIGAS UNIT, MODEL AG-920RA | CCK | Substantially Equivalent | |
| K011918 | NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES | MHX | Substantially Equivalent | |
| K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES | IKN | Substantially Equivalent | |
| K011204 | NEUROFAX, MODELS EEG-1100A, EEG-9100A | OLV | Substantially Equivalent | |
| K002068 | ORG-9200A | DSI | Substantially Equivalent | |
| K002473 | WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES | DPS | Substantially Equivalent | |
| K001433 | CNS-9300 SERIES CENTRAL STATION | MHX | Substantially Equivalent | |
| K001693 | LIFE SCOPE P, MODEL BSM-4100 SERIES | MHX | Substantially Equivalent | |
| K000517 | LIFE SCOPE EC, MODEL BSM-1102 | MHX | Substantially Equivalent | |
| K000338 | VITAPORT 3 | OLV | Substantially Equivalent | |
| K992455 | NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES | DQA | Substantially Equivalent | |
| K992742 | NEUROFAX, MODEL EEG-1100A | OLV | Substantially Equivalent | |
| K991899 | NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES | GWF | Substantially Equivalent | |
| K990063 | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES | CCK | Substantially Equivalent | |
| K990031 | NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES | LOS | Substantially Equivalent | |
| K984504 | NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES | LOS | Substantially Equivalent | |
| K983072 | AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 | OLV | Substantially Equivalent | |
| K974292 | NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES | DQA | Substantially Equivalent | |
| K973918 | NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES | DRT | Substantially Equivalent | |
| K971436 | NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES | LDD | Substantially Equivalent - Subject to Tracking Reg. | |
| K972310 | NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K971355 | NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES | LDD | Substantially Equivalent - Subject to Tracking Reg. |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2080783 | 2080783 | NIHON KOHDEN AMERICA, INC. | 15353 Barranca Pkwy, Irvine, CA 92618 US | 2026 | and 39 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRQAmplifier And Signal Conditioner, Transducer Signal
- GWLAmplifier, Physiological Signal
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- BXAAnalyzer, Gas, Water Vapor, Gaseous-Phase
- GWSAnalyzer, Spectrum, Electroencephalogram Signal
- BTYCalculator, Predicted Values, Pulmonary Function
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- GWKConditioner, Signal, Physiological
- BZAConnector, Airway (Extension)
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- GZODevice, Galvanic Skin Response Measurement
- JXEDevice, Nerve Conduction Velocity Measurement
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- GYCElectrode, Cortical
- GXYElectrode, Cutaneous
- JJPElectrode, Ion Selective (Non-Specified)
- IKTElectrode, Needle, Diagnostic Electromyograph
- IKNElectromyograph, Diagnostic
- MNKEndoscopic Bite Block
- DPWFlowmeter, Blood, Cardiovascular
- GWQFull-Montage Standard Electroencephalograph
- KGKGas, Collecting Vessel
- HPPHeadlamp, Operating, Battery-Operated
- CCWLaryngoscope, Rigid
- GYBMedia, Electroconductive
- KMIMonitor, Bed Patient
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- HXBProbe
- KAKProbe, Ent
- IZDProbe, Uptake, Nuclear
- FRNPump, Infusion
- DSFRecorder, Paper Chart
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- KOIStimulator, Nerve, Peripheral, Electric
- GWEStimulator, Photic, Evoked Response
- IOYSupport, Arm
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
- KGXTape And Bandage, Adhesive
- GYATester, Electrode/Lead, Electroencephalograph
- DRSTransducer, Blood-Pressure, Extravascular
- BXOTransducer, Gas Pressure
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0268-2025 | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | Class II | Open, Classified | |
| Z-0267-2025 | 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. | Class II | Open, Classified | |
| Z-2025-2024 | 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 medical facility. | Due to software issue the device may give false "SpO2 Probe Failure" alarm | Class II | Open, Classified | |
| Z-0314-2025 | 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 intended for single patient use only. | Due to products being shipped/distributed to customers after the products expiration date had past. | Class II | Open, Classified | |
| Z-1162-2021 | 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. | Class II | Open, Classified | |
| Z-0865-2021 | 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 intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies. | Medical device non-conformance to electrical safety standard (IEC 60601-1). | Class II | Open, Classified | |
| Z-1768-2017 | 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. | Class II | Terminated | |
| Z-1543-2015 | 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 multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are detected. | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound. | Class II | Terminated | |
| Z-1979-2014 | 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. | Class II | Terminated | |
| Z-0817-2016 | 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. | Class II | Terminated | |
| Z-0218-2007 | 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. | Terminated | ||
| Z-0506-04 | AG-920RA Multi-gas unit analyzer | Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain