# K253212: XR-Series (XR-10, XR-20) Automated Hematology Analyzers

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: May 27, 2026 after 240 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: 4 generations back to K040073 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250943: Sysmex XR-Series (XR-10) Automated Hematology Analyzer, Sysmex America, Inc. (2025) Summary page 6.
- K251371: Sysmex XR-Series (XR-20) Automated Hematology Analyzer, Sysmex America, Inc. (2025) Summary page 6.

## Indications for use
The XR-Series System Configurations (XR-1500, XR-2000, XR-3000 and XR-9000) are a family of integrated modular quantitative multi-parameter, automated hematology analyzer configurations intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XR Series System Configurations consist of one or more XR-Series automated hematology analyzers (XR-10 and/or XR-20) and may include an automated slide preparation unit (SP-50). The XR-2000 configuration consists of two XR-Series automated hematology analyzers (XR-10 and/or XR-20), the XR-1500/XR-3000 configurations consist of up to two XR-Series automated hematology analyzers (XR-10 and/or XR-20) and an automated slide preparation unit (SP-50), and the XR-9000 configuration consists of up to nine XR-Series automated hematology analyzers (XR-10 and/or XR-20) and an automated slide preparation unit (SP-50). The XR-Series analyzer modules (XR-10, XR-20) classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IPF#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA anticoagulant, and serous and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

Source page: https://510kreport.com/device/K253212
Methodology: https://510kreport.com/methodology