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Data / Medical devices / Japan / Sysmex Corporation

Sysmex Corporation: FDA-registered device maker in KOBE Hyogo, Japan, 19 510(k) clearances

Sysmex Corporation is registered with the FDA (registration 3010421384) in KOBE Hyogo, Japan. It lists 21 device types. The FDA files 19 510(k) clearances under its listings, the newest dated June 25, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Sysmex Corporation
FDA registration number
3010421384
Address
4-4-4 Takatsukadai Nishi-Ku, KOBE Hyogo, Japan, 651-2271
Owner or operator
SYSMEX CORPORATION (9014170)
Roles
Exporter to the US, Manufacturer
First device listed
May 6, 1998
Registered through
2027
Brand names listed
AUTOMATED HEMATOLOGY ANALYZER XW-100, AlphaN-SPSU, AlphaN-XESU, Automated Blood Coagulation Analyzer CN-3000, Automated Blood Coagulation Analyzer CN-6000, Automated Immunoassay System HISCL-800, BT-50, Barcode Terminal (BT-40) and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufactureraccessdata.fda.gov
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisPER1Exporter to the USaccessdata.fda.gov
Calibrator, SecondaryJIT2Manufactureraccessdata.fda.gov
Calibrator, SurrogateJIW2Exporter to the USaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the USaccessdata.fda.gov
Counter, Cell, Automated (Particle Counter)GKL2Exporter to the USaccessdata.fda.gov
Counter, Differential CellGKZ2Exporter to the USaccessdata.fda.gov
Counter, Urine ParticleLKM2Exporter to the USaccessdata.fda.gov
Device, Automated Cell-LocatingJOY2Exporter to the USaccessdata.fda.gov
Diluent, Blood CellGIF1Exporter to the USaccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Exporter to the USaccessdata.fda.gov
General Purpose ReagentPPM1Exporter to the USaccessdata.fda.gov
Instrument, Coagulation, AutomatedGKP2Exporter to the USaccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Manufactureraccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Manufactureraccessdata.fda.gov
Slide Stainer, AutomatedKPA1Exporter to the USaccessdata.fda.gov
Stain, ReticulocyteGJH1Exporter to the USaccessdata.fda.gov
Stains, HematologyKQC1Exporter to the USaccessdata.fda.gov
System, Multipurpose For In Vitro Coagulation StudiesJPA2Exporter to the USaccessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)JJW1Exporter to the USaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 25, 2025K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
June 25, 2025K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
June 2, 2025K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPASubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
December 21, 2023K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
November 8, 2022K210346Sysmex XW-100 Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
October 30, 2018K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOYSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
April 23, 2018K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKMSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
November 6, 2017K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
December 22, 2016K160538Sysmex XN-L Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
October 21, 2016K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlJLWSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
January 26, 2016K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPASubstantially EquivalentSiemens Healthcare Diagnostics Products GmbHaccessdata.fda.gov
January 11, 2016K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPASubstantially EquivalentSiemens Healthcare Diagnostic Products GmbHaccessdata.fda.gov
December 5, 2014K141681SYSMEX XN SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
October 19, 2012K112605SYSMEX XN-SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
February 11, 2004K032677SYSMEX POCH-100IGKLSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
September 8, 2003K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560GKPSubstantially EquivalentDade Behring, Inc.accessdata.fda.gov
June 27, 2002K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000GKPSubstantially EquivalentDade Behring, Inc.accessdata.fda.gov
July 20, 2001K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPASubstantially EquivalentDade Behring, Inc.accessdata.fda.gov
August 14, 1998K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKLSubstantially EquivalentSysmex Corp.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 18, 201470054Class IITerminatedThe XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.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.