Company ยท US
Nihon Kohden America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2012. Name variants (Inc, Corp, punctuation) are merged.
166510(k) clearances (0 in 12 months)
13recalls (1 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DPS | Electrocardiograph | 21 |
| DSI | Detector And Alarm, Arrhythmia | 18 |
| GWQ | Full-Montage Standard Electroencephalograph | 16 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 16 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 11 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 10 |
| GWF | Stimulator, Electrical, Evoked Response | 9 |
| OLV | Standard Polysomnograph With Electroencephalograph | 9 |
| DQA | Oximeter | 8 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 8 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 6 |
| LOS | 4 | |
| BZQ | Monitor, Breathing Frequency | 3 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 3 |
| DXJ | Display, Cathode-Ray Tube, Medical | 3 |
| GWL | Amplifier, Physiological Signal | 3 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 2 |
| DSF | Recorder, Paper Chart | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2012 | K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX Nihon Kohden America, Inc. | GWQ |
| Mar 16, 2012 | K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P Nihon Kohden America, Inc. | OMA |
| Jul 9, 2010 | K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM Nihon Kohden America, Inc. | OMA |
| Mar 2, 2009 | K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P Nihon Kohden America, Inc. | CCK |
| Dec 24, 2008 | K083271 | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY Nihon Kohden America, Inc. | MHX |
| Nov 26, 2008 | K082785 | NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES Nihon Kohden America, Inc. | MHX |
| Oct 6, 2008 | K071969 | SEN-4100 ELECTRIC STIMULATOR Nihon Kohden America, Inc. | GWF |
| Aug 29, 2008 | K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A Nihon Kohden America, Inc. | OLT |
| Mar 28, 2008 | K073550 | PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION Nihon Kohden America, Inc. | MHX |
| Feb 26, 2008 | K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES Nihon Kohden America, Inc. | MHX |
| Jan 11, 2008 | K073491 | EEG-1100A SWITCH BOX Nihon Kohden America, Inc. | OLV |
| Nov 29, 2007 | K072843 | YG-125T AND YG-135T NASAL ADAPTER Nihon Kohden America, Inc. | CCK |
| Aug 30, 2007 | K072217 | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M Nihon Kohden America, Inc. | DPS |
| Aug 17, 2007 | K072060 | QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V Nihon Kohden America, Inc. | DPS |
| Jun 29, 2007 | K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A Nihon Kohden America, Inc. | DRG |
| Dec 27, 2006 | K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A Nihon Kohden America, Inc. | CCK |
| May 24, 2006 | K052511 | CARDIOFAX CE, MODEL ECG-1500 A Nihon Kohden America, Inc. | DPS |
| Aug 17, 2005 | K051178 | MEE-1000A NEUROMASTER Nihon Kohden America, Inc. | GWF |
| Apr 29, 2005 | K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A Nihon Kohden America, Inc. | OLV |
| Feb 3, 2005 | K043517 | TRANSMITTER, ZS-940PA SERIES Nihon Kohden America, Inc. | DRT |
| Jan 6, 2005 | K042827 | CARDIOFAX CE, MODEL PEA-1110K Nihon Kohden America, Inc. | DPS |
| Oct 15, 2004 | K040875 | CAP-ONE, MODEL TG-920P Nihon Kohden America, Inc. | CCK |
| Jun 1, 2004 | K040395 | CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES Nihon Kohden America, Inc. | MHX |
| Jan 7, 2004 | K033475 | WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES Nihon Kohden America, Inc. | OLV |
| Sep 16, 2003 | K032749 | BEDSIDE MONITOR, MODEL OPV-1500 Nihon Kohden America, Inc. | MWI |
| Mar 4, 2003 | K030105 | ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A Nihon Kohden America, Inc. | MHX |
| Oct 24, 2002 | K023475 | CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES Nihon Kohden America, Inc. | MHX |
| Jul 29, 2002 | K022121 | PSG INPUT BOX, MODEL JE-912AK Nihon Kohden America, Inc. | OLV |
| Jul 25, 2002 | K020046 | MULTIGAS UNIT, MODEL AG-920RA Nihon Kohden America, Inc. | CCK |
| Sep 12, 2001 | K011918 | NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES Nihon Kohden America, Inc. | MHX |
| Jun 28, 2001 | K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES Nihon Kohden America, Inc. | IKN |
| May 8, 2001 | K011204 | NEUROFAX, MODELS EEG-1100A, EEG-9100A Nihon Kohden America, Inc. | OLV |
| Feb 8, 2001 | K002068 | ORG-9200A Nihon Kohden America, Inc. | DSI |
| Nov 8, 2000 | K002473 | WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES Nihon Kohden America, Inc. | DPS |
| Nov 7, 2000 | K001433 | CNS-9300 SERIES CENTRAL STATION Nihon Kohden America, Inc. | MHX |
| Oct 24, 2000 | K001693 | LIFE SCOPE P, MODEL BSM-4100 SERIES Nihon Kohden America, Inc. | MHX |
| Aug 31, 2000 | K000517 | LIFE SCOPE EC, MODEL BSM-1102 Nihon Kohden America, Inc. | MHX |
| Apr 26, 2000 | K000338 | VITAPORT 3 Nihon Kohden America, Inc. | OLV |
| Jan 7, 2000 | K992455 | NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES Nihon Kohden America, Inc. | DQA |
| Oct 14, 1999 | K992742 | NEUROFAX, MODEL EEG-1100A Nihon Kohden America, Inc. | OLV |
| Sep 1, 1999 | K991899 | NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES Nihon Kohden America, Inc. | GWF |
| Jun 9, 1999 | K990063 | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES Nihon Kohden America, Inc. | CCK |
| Apr 16, 1999 | K990031 | NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES Nihon Kohden America, Inc. | LOS |
| Apr 15, 1999 | K984504 | NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES Nihon Kohden America, Inc. | LOS |
| Dec 1, 1998 | K983072 | AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 Nihon Kohden America, Inc. | OLV |
| Jun 8, 1998 | K974292 | NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES Nihon Kohden America, Inc. | DQA |
| Jan 13, 1998 | K973918 | NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES Nihon Kohden America, Inc. | DRT |
| Oct 21, 1997 | K971436 | NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES Nihon Kohden America, Inc. | LDD |
| Aug 20, 1997 | K972310 | NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH Nihon Kohden America, Inc. | DPS |
| Jul 15, 1997 | K971355 | NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES Nihon Kohden America, Inc. | LDD |
Newest 50 of 166.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2026 | Nihon Kohden America LLC 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 Descrip Open, Classified |
MHX | K102376 |
| Nov 6, 2024 | Nihon Kohden America Inc 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. Open, Classified |
CCK | K171765 |
| Oct 30, 2024 | Nihon Kohden America Inc Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007
Reusable SpO2 Ear Clip, each Open, Classified |
DQA | None listed |
| Oct 30, 2024 | Nihon Kohden America Inc Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006
Disp. SpO2 Forehead Probe, Adult, 10/Box Open, Classified |
DQA | None listed |
| Jun 6, 2024 | Nihon Kohden America Inc 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 Open, Classified |
MHX | None listed |
| Jan 14, 2021 | Nihon Kohden America Inc 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 di Open, Classified |
GWQ | K120888 |
| Jan 8, 2021 | Nihon Kohden America Inc WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI:
ORG 9100A/ 00841983102554
ORG 9110A/ 00841983102561
ORG 9700A/No UDI Open, Classified |
DRG | K071058 |
| Mar 20, 2017 | Nihon Kohden America Inc 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). Terminated |
MHX | K151080 |
| Feb 17, 2016 | Nihon Kohden America Inc MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG) Terminated |
GWF | K051178 |
| Apr 29, 2015 | Nihon Kohden America Inc 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 Terminated |
MHX | K023475 |
| Jul 2, 2014 | Nihon Kohden America Inc CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201
For cardiac and vital signs monitoring for multiple patients. Terminated |
MHX | K102376 |
| Nov 28, 2006 | Nihon Kohden America Inc Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System) Terminated |
GWF | K991899 |
| Jan 31, 2004 | Nihon Kohden America Inc AG-920RA Multi-gas unit analyzer Terminated |
CCK | None listed |