Nihon Kohden America Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 166
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0268-2025 | Class II | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each | September 18, 2024 |
| Z-0267-2025 | Class II | Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 For | September 18, 2024 |
| Z-2025-2024 | Class II | BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring S | April 29, 2024 |
| Z-0314-2025 | Class II | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administe | April 29, 2022 |
| Z-1162-2021 | Class II | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 | January 8, 2021 |
| Z-0865-2021 | Class II | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; | December 21, 2020 |
| Z-1768-2017 | Class II | Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901 | March 13, 2017 |
| Z-1543-2015 | Class II | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40 | April 14, 2015 |
| Z-1979-2014 | Class II | CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vi | June 3, 2014 |
| Z-0817-2016 | Class II | MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stim | January 19, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX | March 22, 2012 |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | March 16, 2012 |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | July 9, 2010 |
| K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | March 2, 2009 |
| K083271 | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSO | December 24, 2008 |
| K082785 | NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES | November 26, 2008 |
| K071969 | SEN-4100 ELECTRIC STIMULATOR | October 6, 2008 |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | August 29, 2008 |
| K073550 | PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION | March 28, 2008 |
| K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES | February 26, 2008 |
| K073491 | EEG-1100A SWITCH BOX | January 11, 2008 |
| K072843 | YG-125T AND YG-135T NASAL ADAPTER | November 29, 2007 |
| K072217 | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M | August 30, 2007 |
| K072060 | QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V | August 17, 2007 |
| K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A | June 29, 2007 |
| K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | December 27, 2006 |
| K052511 | CARDIOFAX CE, MODEL ECG-1500 A | May 24, 2006 |
| K051178 | MEE-1000A NEUROMASTER | August 17, 2005 |
| K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A | April 29, 2005 |
| K043517 | TRANSMITTER, ZS-940PA SERIES | February 3, 2005 |