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Nihon Kohden America Fulfillment Center: FDA-registered device maker in Foothill Ranch, CA, United States, 9 510(k) clearances

Name: Nihon Kohden America Fulfillment Center FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nihon Kohden America Fulfillment Center is registered with the FDA (registration 3030154814) in Foothill Ranch, CA, United States. It lists 9 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 9, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030154814
Address: 20091 Ellipse, Suite 100, Foothill Ranch, CA, United States, 92610
Owner or operator: NIHON KOHDEN CORP. (8030227)
Roles: Manufacturer, Repackager or relabeler
First device listed: October 31, 2007
Registered through: 2026
Brand names listed: A/NTX-DISP, A/NTX2-POUCH, BA-903D, BR-903PA, BR-906PA, BR-913PA, BR-916PA, CARBON DIOXIDE MONITOR, MODEL OLG-2800A and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrocardiograph	DPS	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	2	Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 9, 2025	K251366	EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)	OLT	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
June 10, 2025	K243956	TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)	CCK	Substantially Equivalent	Nihon Kohden Corporation	accessdata.fda.gov
August 30, 2007	K072217	ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M	DPS	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
June 29, 2007	K071058	MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A	DRG	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
December 27, 2006	K062115	CARBON DIOXIDE MONITOR, MODEL OLG-2800A	CCK	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
August 17, 2005	K051178	MEE-1000A NEUROMASTER	GWF	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
April 29, 2005	K050833	ELECTRODE JUNCTION BOX, MODEL JE-921A	OLV	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
February 3, 2005	K043517	TRANSMITTER, ZS-940PA SERIES	DRT	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov
October 15, 2004	K040875	CAP-ONE, MODEL TG-920P	CCK	Substantially Equivalent	Nihon Kohden America, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.