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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 3 of 6

Device	Model / Reference	Registries	Class	Status
Cardiofax-V Ecg-8110a	K873874	FDA 510(k)	Class II	Active
Eeg-4300 W/Optinal Access. Eeg 4314 &	K842714	FDA 510(k)	Class II	Active
Meb-5200	K854664	FDA 510(k)	Class II	Active
Mpv-7201 Non-Invasive Blood Pressure Monitor	K854370	FDA 510(k)	Class II	Active
Model Eeg-4214 Electroencephalograph	K791233	FDA 510(k)	Class II	Active
Mtc 6210a Cardiac Output Computer	K854371	FDA 510(k)	Class II	Active
Nihon Kohden Ecg-9010k And Ecg-9020k Cardiofax Gem And Accessories	K990031	FDA 510(k)	N/A	Active
Nihon Kohden Tg-901t Co2 Sensor Kit With Accessories	K990063	FDA 510(k)	Class II	Active
Model Eeg-4217 Electroencephalograph	K791234	FDA 510(k)	Class II	Active
Nihon Kohden Heart Monitors Omp 7101-02	K813444	FDA 510(k)	Class II	Active
Cardiofax-V Ecg-8240a	K865030	FDA 510(k)	Class II	Active
Psg Input Box, Model Je-912ak	K022121	FDA 510(k)	Class II	Active
Electrocardiograph Model Ecg-5403	K791540	FDA 510(k)	Class II	Active
Ecg-1250a Series Cardiofax S And Ecg-1350a Series Cardiofax M	K072217	FDA 510(k)	Class II	Active
Cardiofax Ecg 6543	K840274	FDA 510(k)	Class II	Active
Dual Lead (ecg1 & Ecg2) Arrhythmia Analysis	K920743	FDA 510(k)	Class II	Active
Electroencephalographs Models 7209, 7213	K791150	FDA 510(k)	Class II	Active
Neurofile Data Storage/Accesories To The Eeg-4300	K905594	FDA 510(k)	Class II	Active
Nihon Kohden Co2 Sensor Kit, Model Tg-970p	K083456	FDA 510(k)	Class II	Active
Life Scope P, Model Bsm-4100 Series	K001693	FDA 510(k)	Class II	Active
Ap-851pa Nibp Module	K894693	FDA 510(k)	Class II	Active
Arrhythmia Central-Ogp-7201	K844911	FDA 510(k)	Class II	Active
Neurofax Eeg 5532	K915096	FDA 510(k)	Class II	Active
Nihon Kohden Qp-932e Ecg Exercise Test Option For The Nihon Kohden Ecg-9320/A Cardiofax Electrocardiograph	K972310	FDA 510(k)	Class II	Active
Model Eeg 4221	K802887	FDA 510(k)	Class II	Active
4312p Polysomnograph Electoenciphalograph	K854665	FDA 510(k)	Class II	Active
Omf-7101 Fetal Monitor	K860237	FDA 510(k)	Class II	Active
Eeg-5400 Series	K902550	FDA 510(k)	Class II	Active
Nihon Kohden Electroencephalograph	K944678	FDA 510(k)	Class II	Active
Nihon Kohden Tec-7511a/Tec-7521a Cardiolife Portable Defibrillator And Accessories	K971436	FDA 510(k)	Class II	Active
Cardiofax Ecg-8830a	K904758	FDA 510(k)	Class II	Active
Electrocardiograph	K865031	FDA 510(k)	Class II	Active
Nihon Kohden Meb-2200a Neuropack Evoked Potential & Emg Measuring System With Accessories	K991899	FDA 510(k)	Class II	Active
Bsm-8800a Bedside Monitor	K944422	FDA 510(k)	Class II	Active
Model Rm 6000, 6100, 6200 Polygraph	K823281	FDA 510(k)	Class II	Active
Electronic Spirometer Model Mfr-8100	K810712	FDA 510(k)	Class II	Active
Lifescope 12, Bsm 8500a Patient Monitor	K872241	FDA 510(k)	Class II	Active
Bsm-2100a Configured Patient Monitor	K914092	FDA 510(k)	Class II	Active
Bedside Monitor, Model Opv-1500	K032749	FDA 510(k)	Class II	Active
Nka Models Ab-601g And Ab-621g	K900272	FDA 510(k)	Class II	Active
Sls 3500 Led Visual Stimulator	K842381	FDA 510(k)	Class II	Active
Central Telemetry System, Model Wep-4200a Series	K040395	FDA 510(k)	Class II	Active
Electrocardiograph, Model Ecg-5151	K792229	FDA 510(k)	Class II	Active
Org-9200a	K002068	FDA 510(k)	Class II	Active
Cardiofax Q Ecg-8420a	K922394	FDA 510(k)	N/A	Active
Nihon Kohden Wep-8430a Central Telemetry System	K945944	FDA 510(k)	Class II	Active
Skin Pure	K862799	FDA 510(k)	Class II	Active
Nihon Kohden Bsm-1101 And Bsm-1102 Patient Monitor And Accessories	K973918	FDA 510(k)	Class II	Active
Nihon Kohden Bedside Monitor, Bsm 9100a Series	K082785	FDA 510(k)	Class II	Active
Wec-7101a Pocket Size Ecg Monitor And Accessories	K002473	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.