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Sysmex

Diagnostics makerAI in JapanAI. FDA records under 2 spellings of its name, each linked to the record.

  • Records across the group: 103, 7 entitiesAI
  • 510(k) clearances: 65
  • Device recalls: 38

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sysmex and its 6 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
May 27, 2026XR-Series (XR-10, XR-20) Automated Hematology AnalyzersK253212 · GKZ510(k) clearances
Jun 25, 2025Sysmex XR-Series (XR-20) Automated Hematology AnalyzerK251371 · GKZ510(k) clearances
Jun 25, 2025Sysmex XR-Series (XR-10) Automated Hematology AnalyzerK250943 · GKZ510(k) clearances
Jun 2, 2025Automated Blood Coagulation Analyzer CN-Series (CN-6000)K250965 · JPA510(k) clearances
Dec 21, 2023Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerK230887 · GKZ510(k) clearances
Nov 8, 2022Sysmex XW-100 Automated Hematology AnalyzerK210346 · GKZ510(k) clearances
Jan 25, 2019Sysmex XN-L Automated Hematology AnalyzerK182389 · GKZ510(k) clearances
Oct 30, 2018Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceK182062 · JOY510(k) clearances
Dec 18, 2014The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use inClass II · There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.Device recalls

Subsidiaries and Divisions

6 firms in the Sysmex group, most records first

Canada and Imports

Across the Sysmex group, matched by company name
Active Health Canada device licences
75, as of Nov 10, 2026

Names and Identifiers

Appears as
Sysmex Corp.Sysmex Corporation

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.