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NIHON KOHDEN AMERICA, INC.

Last updated September 17, 2026

Information

Country: US
Address: 15353 Barranca Pkwy, Irvine, CA, 92618
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2080783
DUNS Number: —

Catalogue (255)

Page 4 of 6

Device	Model / Reference	Registries	Class	Status
Ar-800pa Respiration Module	K891486	FDA 510(k)	Class II	Active
Cns-9300 Series Central Station	K001433	FDA 510(k)	Class II	Active
Nka Model Sec-3102 Cardiac Stimulator	K894492	FDA 510(k)	Class II	Active
Nihon Kohden Zb-831pa Telemetry Transmitter	K946175	FDA 510(k)	Class II	Active
Lifescope 8 Dec-8108a And Dec-8204a	K852270	FDA 510(k)	Class II	Active
Oec-7102 Ecg/Nibp Monitor	K882254	FDA 510(k)	Class II	Active
Tfv-2300 Infusion Pump	K890736	FDA 510(k)	Class II	Active
Ecg Monitor Oscilloscope Model Oec-3200	K800004	FDA 510(k)	Class II	Active
Lifescope Ii/Four	K823249	FDA 510(k)	Class II	Active
Electroencephalograph	K823140	FDA 510(k)	Class II	Active
Cardiolife Tec 7200	K863405	FDA 510(k)	Class II	Active
Cardiofax Ecg-6551 (electrocardiogrph)	K863116	FDA 510(k)	Class II	Active
Arrhythmia Central Occ-7101	K843287	FDA 510(k)	Class II	Active
Oee_7102 Eeg/Trend Monitor	K854662	FDA 510(k)	Class I	Active
Carbon Dioxide Monitor, Model Olg-2800a	K062115	FDA 510(k)	Class II	Active
Qp-156e Ecg Exercise Test Option For The Ecg-1500a Series/Cardiofax V	K072060	FDA 510(k)	Class II	Active
Neurofax, Model Eeg-1100a	K992742	FDA 510(k)	Class II	Active
Cns-8200a Central Nurses Station	K884050	FDA 510(k)	Class II	Active
Wep 7604 Telemetry Monitor	K854369	FDA 510(k)	Class II	Active
Neuropack Micro, Model Med-9100a Series	K010590	FDA 510(k)	Class II	Active
Neurofax 7310 Series (eeg)	K854663	FDA 510(k)	Class II	Active
Elefix Electrode Cream	K860210	FDA 510(k)	Class II	Active
Wlectrocardiograph Ecg-7204	K831274	FDA 510(k)	Class II	Active
Nihon Kohden Eeg-1200a Series Neurofax, Model Eeg-1200a	K080546	FDA 510(k)	Class II	Active
Model Eeg 4400 With Optional Accessories	K874796	FDA 510(k)	Class II	Active
Sen-4100 Electric Stimulator	K071969	FDA 510(k)	Class II	Active
Mlc-4200 Cardiac Output Computer	K802305	FDA 510(k)	Class II	Active
Vitaport 3	K000338	FDA 510(k)	Class II	Active
Model Vy-800ra Optional Accessory To Bsm 8500a	K883973	FDA 510(k)	Class II	Active
Lifescope 8, Oec-8120 Portable Patient Monitor Rec	K862463	FDA 510(k)	Class II	Active
Olv 1100; Olv 1200 Pulse Oximeters	K881307	FDA 510(k)	Class II	Active
Display Monitor (vd-711ra-Vd-712ra)	K850343	FDA 510(k)	Class II	Active
Nihon Kohden Tl-101t, Tl-120t And Tl-121t Spo2 Probes And Accessories	K974292	FDA 510(k)	Class II	Active
Models Wep-8410a And Wep-8420a Telemetry Central	K901034	FDA 510(k)	Class II	Active
Nihon Kohden Ogs-2001a Pocketcare And Accessories	K992455	FDA 510(k)	Class II	Active
Cardiac Output Computer, M-Mlc-4100	K792678	FDA 510(k)	Class II	Active
Nka Model Mfv-3100 & Mfv-3200 Electro. Blood Flow.	K894631	FDA 510(k)	Class II	Active
Nihon Kohden Olg-100a Pocketcap Pocket Co2 Monitor With Accessories	K964305	FDA 510(k)	Class II	Active
Nihon Kohden Tec-7531 Cardiolife Portable Defibrillator And Accessories	K971355	FDA 510(k)	Class II	Active
Mem-4104 Evoked Response/Electromyography Recorder	K870794	FDA 510(k)	Class II	Active
C02 Monitor-Oir-7101	K841498	FDA 510(k)	Class II	Active
Vm 781 Slave Scope	K854372	FDA 510(k)	Class II	Active
Urethral Pressure Profile & Temp. Modul	K823561	FDA 510(k)	Class II	Active
Al-800pa Pulse Oximeter Module	K884536	FDA 510(k)	Class II	Active
Wep-8430a Telemetry Central Station	K904696	FDA 510(k)	Class II	Active
Zb-860pa Multiparameter Transmitter	K913117	FDA 510(k)	Class II	Active
Lifescope 6 Oec-6201	K841500	FDA 510(k)	Class II	Active
Ecg Monitor Oscilloscope Model Oec-3100	K800005	FDA 510(k)	Class II	Active
Nihon Kohden Zb-821 Telemetry Transmitter	K945578	FDA 510(k)	Class II	Active
Electrode Junction Box, Model Je-921a	K050833	FDA 510(k)	Class II	Active

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 18, 2024	Z-0267-2025	—	open, classified	Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Sep 18, 2024	Z-0268-2025	—	open, classified	Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Apr 29, 2024	Z-2025-2024	—	open, classified	Due to software issue the device may give false "SpO2 Probe Failure" alarm
Apr 29, 2022	Z-0314-2025	—	open, classified	Due to products being shipped/distributed to customers after the products expiration date had past.
Jan 8, 2021	Z-1162-2021	—	open, classified	Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Dec 21, 2020	Z-0865-2021	—	open, classified	Medical device non-conformance to electrical safety standard (IEC 60601-1).
Mar 13, 2017	Z-1768-2017	—	terminated	The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Apr 14, 2015	Z-1543-2015	—	terminated	Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Jun 3, 2014	Z-1979-2014	—	terminated	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.
Jan 19, 2012	Z-0817-2016	—	terminated	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.
Aug 23, 2006	Z-0218-2007	—	terminated	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.
Dec 5, 2003	Z-0506-04	—	terminated	Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough.