Is this your brand? Sign in to claim ownership.

NIHON KOHDEN AMERICA, INC.

Last updated September 17, 2026

Information

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

Catalogue (255)

Page 2 of 6

Device	Model / Reference	Registries	Class	Status
cap-ONE	TG-920P	FDA UDI	Class II	Active
Life Scope G9	A/CE620NK	FDA UDI	Class II	Active
Life Scope G9	A/326391 CABLE	FDA UDI	Class II	Active
Life Scope VS	BSM-3572	FDA UDI	Class II	Active
BluPRO®	TL-220T	FDA UDI	Class II	Active
Patient Triage Solution	SVM-NEL-R-EX-HP-ZA	FDA UDI	Class II	Active
BluPRO®	TL-272T3	FDA UDI	Class II	Active
cap-ONE	YG-235T	FDA UDI	Class II	Active
NK-HealthProtect Wireless Surge Solution	A-WSS-002-ZA	FDA UDI	Class II	Active
Life Scope TR	MU-651RA	FDA UDI	Class II	Active
skinPure	YZ-0019	FDA UDI	Class II	Active
Neuropack S3	NPS3-LT-Cart4-ZA	FDA UDI	Class II	Active
Emergency Response System	A-WSS-001-ZA	FDA UDI	Class II	Unknown
Gcx	A/SONYCART	FDA UDI	Class II	Active
Neurofax	NK-REVSUITE-10	FDA UDI	Class II	Active
Neurofax	EEG-9100A	FDA UDI	Class II	Active
Neuropack	MEB-9400A-DT	FDA UDI	Class II	Active
Life Scope VS	BSM-3532	FDA UDI	Class II	Active
Neurofax	JE-120A-22	FDA UDI	Class II	Active
Neuromaster G1	DC-200B	FDA UDI	Class II	Active
Life Scope PT	BSM-1773	FDA UDI	Class II	Active
Polysmith Sleep System	A/ONEBED-SCORE-10X	FDA UDI	Class II	Active
EEG Trend Program	QP-160R-10	FDA UDI	Class II	Active
Elefix	Z-401CE	FDA UDI	Class II	Active
Modo	A/NIH8000	FDA UDI	Class II	Active
Polysmith Sleep System	A/ONEBED-SCORE-11X	FDA UDI	Class II	Active
Neuromaster	MEE-2000A-DT	FDA UDI	Class II	Active
VitalEEG Portable System	AE-120A	FDA UDI	Class II	Active
cardiofax S	ECG-1250A	FDA UDI	Class II	Active
BluPRO®	TL-201T	FDA UDI	Class II	Active
Life Scope G9	A/EJ110-0010 CABLE	FDA UDI	Class II	Active
Neuromaster	DC-110BA	FDA UDI	Class II	Active
BluPRO®	TL-220T	FDA UDI	Class II	Active
Life Scope G9	CU-192R	FDA UDI	Class II	Active
VitalEEG Portable System	AE-120A	FDA UDI	Class II	Active
Life Scope G9	YS-19003	FDA UDI	Class II	Active
BluPRO®	TL-271T	FDA UDI	Class II	Active
Life Scope VS	BSM-3552	FDA UDI	Class II	Active
Life Scope G9	G9-KVM/ZA	FDA UDI	Class II	Active
Emg Electrodes And Extension Cords	K870795	FDA 510(k)	Class II	Active
Ag-839pa Co2 Module And Accessories	K944027	FDA 510(k)	Class I	Active
Neuropack Ii 5100	K841612	FDA 510(k)	Class II	Active
Org-8200a Universal Signal Housing	K912744	FDA 510(k)	Class II	Active
Cap-One, Model Tg-920p	K040875	FDA 510(k)	Class II	Active
Eeg & Respiration Modules Polygraph	K823563	FDA 510(k)	Class II	Active
Bedside Monitors, Bsm-8301a, Bsm-8302a	K894692	FDA 510(k)	Class II	Active
Ag-820pa Fi02 Module	K896359	FDA 510(k)	Class II	Active
Neurofax, Models Eeg-1100a, Eeg-9100a	K011204	FDA 510(k)	Class II	Active
Emg Modules For Polygraph System	K823562	FDA 510(k)	Class II	Active
Bsm-8800a Bedside Monitor	K920154	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.