SYSMEX E-2500 Automated Hematology System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K855117 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Sysmex K-1000 18 Parameter, Auto. Hema Analyzer

  Class II

  FDA 510(k) K882370 Active Cleared 25 Aug 1988

• Ca-1000 Automated Coagulation Analyzer

  Class II

  FDA 510(k) K931149 Active Cleared 3 Nov 1993

• Sysmex Hematological Whole Blood Diluting Reagent-

  Class I

  FDA 510(k) K850239 Active Cleared 1 Apr 1985

• Microcell Counter Model Cc-108

  Class II

  FDA 510(k) K780224 Active Cleared 19 May 1978

• Sysmex Ne-8000

  Class II

  FDA 510(k) K883997 Active Cleared 5 Dec 1988

• Sysmex Ne-1500, Modification

  Class II

  FDA 510(k) K914744 Active Cleared 30 Dec 1991

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• What is the SYSMEX E-2500 Automated Hematology System used for?

  The SYSMEX E-2500 is designed for automated analysis of blood samples in clinical laboratories. It performs key hematology tests, including differential white blood cell counts, hemoglobin measurements, and platelet estimations, to support diagnostic evaluations. This system helps clinicians assess blood health efficiently and accurately, reducing manual labor and potential human error in routine hematology assessments.

• How is the SYSMEX E-2500 supplied and what are its operating conditions?

  The SYSMEX E-2500 is supplied as a reusable instrument, meaning it is intended for repeated use in laboratory settings after proper maintenance and cleaning. It operates under non-sterile conditions, which means it is not sterile by design and does not require sterile handling for its intended use. This distinguishes it from single-use devices that must remain sterile until first use.

• Is the SYSMEX E-2500 suitable for MRI environments?

  No, the SYSMEX E-2500 does not require MRI safety considerations. This means the device is not designed to be used within an MRI scanner environment or near strong magnetic fields, and there are no specific MRI safety certifications or warnings associated with it. Laboratories using this system should ensure it is placed in a non-MRI area.

• What regulatory pathway does the SYSMEX E-2500 follow?

  The SYSMEX E-2500 Automated Hematology System is regulated under the FDA 510(k) clearance process, specifically with clearance number K855117. It is classified as a Class II medical device under regulation 864.5220, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. This pathway ensures the device meets safety and effectiveness standards for its intended use in automated hematology analysis.

• What are the key features that distinguish the SYSMEX E-2500 from other hematology analyzers?

  The SYSMEX E-2500 is distinguished by its automated capabilities for performing differential white blood cell counts, hemoglobin measurements, and platelet estimations in a single system. Its design emphasizes rapid and precise results, which are critical for clinical decision-making in hematology. Additionally, its reusable nature and non-sterile operation make it suitable for high-volume laboratory settings where efficiency and reliability are prioritized. These features collectively support its role in streamlining hematology workflows.