# K232946: Yumizen H2500

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: May 21, 2024 after 244 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040073 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112605: Sysmex XN-Series, Sysmex America, Inc. (2012) Summary page 13.

## Most influential descendants
- K260781: Yumizen H550 (2026), 0 descendants of its own

## Indications for use
The Yumizen H2500 is a quantitative multiparameter fully automated hematology analyzer intended for in-vitro diagnostic use in clinical laboratories by qualified healthcare professionals for the screening of patient populations. The Yumizen H2500 is intended to perform tests on the following specimens: Anticoagulated whole blood specimens Body fluids (synovial fluids, serous fluids and cerebrospinal fluids). The Yumizen H2500 classifies and enumerates the following parameters: A complete blood count (CBC) consisting of TNC, WBC, RBC, HGB, calculated HCT, MCV, calculated MCH, calculated MCHC, RDW-SD, RDW-CV, PLT, PLT-Ox, LPF, MPV. A leukocyte differential count consisting of LYM (%/#), MON (%/#), NEU (%/#), EOS (%/#), BAS (%/#), IMG (%/#) A nucleated red blood cell count consisting of NRBC (%/#). A reticulocyte analysis consisting of RET (%/#), calculated CRC, IRF, RHCC. Quantitative determination of blood cells in synovial fluids, serous fluids and cerebrospinal fluids consisting of BFWBC, BFRBC, BFPN (%/#), BFMN (%/#). Note: Venous and capillary whole blood should be collected in K2EDTA anticoagulant. Serous and synovial fluids should be collected without anticoagulant or in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with cerebrospinal fluid specimens is neither required nor recommended. Alternatively, Sodium Heparin or Lithium Heparin may be used for synovial fluid.

Source page: https://510kreport.com/device/K232946
Methodology: https://510kreport.com/methodology