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SYSMEX CORPORATION i-SQUARE: FDA-registered device maker in Kakogawa Hyogo, Japan, 10 510(k) clearances

Name: SYSMEX CORPORATION i-SQUARE FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

SYSMEX CORPORATION i-SQUARE is registered with the FDA (registration 3010960914) in Kakogawa Hyogo, Japan. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 25, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010960914
Address: 262-11 Mizuashi, Noguchicho, Kakogawa Hyogo, Japan, 675-0019
Owner or operator: SYSMEX CORPORATION (9014170)
Roles: Manufacturer
First device listed: July 6, 2011
Registered through: 2027
Brand names listed: AlphaN-SPSU, AlphaN-XESU, Automated Blood Coagulation Analyzer CN-3000, Automated Blood Coagulation Analyzer CN-6000, BT-50, Barcode Terminal (BT-40), CA-7000, CF-60 and more

Devices it lists

Device	Product code	Class	Role	Source
Counter, Differential Cell	GKZ	2	Manufacturer	accessdata.fda.gov
Counter, Urine Particle	LKM	2	Manufacturer	accessdata.fda.gov
Device, Automated Cell-Locating	JOY	2	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Instrument, Coagulation, Automated	GKP	2	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Mixer, Blood Tube	GLE	1	Manufacturer	accessdata.fda.gov
Slide Stainer, Automated	KPA	1	Manufacturer	accessdata.fda.gov
System, Multipurpose For In Vitro Coagulation Studies	JPA	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
June 25, 2025	K251371	Sysmex XR-Series (XR-20) Automated Hematology Analyzer	GKZ	Substantially Equivalent	Sysmex America, Inc.	accessdata.fda.gov
June 25, 2025	K250943	Sysmex XR-Series (XR-10) Automated Hematology Analyzer	GKZ	Substantially Equivalent	Sysmex America, Inc.	accessdata.fda.gov
June 2, 2025	K250965	Automated Blood Coagulation Analyzer CN-Series (CN-6000)	JPA	Substantially Equivalent	Sysmex America, Inc.	accessdata.fda.gov
October 30, 2018	K182062	Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device	JOY	Substantially Equivalent	Sysmex America, Inc.	accessdata.fda.gov
April 23, 2018	K171883	Sysmex UF-5000 Fully Automated Urine Particle Analyzer	LKM	Substantially Equivalent	Sysmex America, Inc.	accessdata.fda.gov
January 26, 2016	K151259	Sysmex Automated Blood Coagulation Analyzer CS-2100i	JPA	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH	accessdata.fda.gov
January 11, 2016	K150678	Sysmex Automated Blood Coagulation Analyzer CS-5100	JPA	Substantially Equivalent	Siemens Healthcare Diagnostic Products GmbH	accessdata.fda.gov
December 5, 2014	K141681	SYSMEX XN SERIES	GKZ	Substantially Equivalent	Sysmex America, Inc.	accessdata.fda.gov
October 19, 2012	K112605	SYSMEX XN-SERIES	GKZ	Substantially Equivalent	Sysmex America, Inc.	accessdata.fda.gov
June 27, 2002	K020979	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000	GKP	Substantially Equivalent	Dade Behring, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 25, 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.