# K112605: Sysmex XN-Series

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Oct 19, 2012 after 408 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040073 (2004). 2 ancestors in all.
20 later devices descend from it; 13 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071967: Sysmex XE-5000, Sysmex America, Inc. (2007) Summary page 4.

## Most influential descendants
- K190898: Sight OLO (2019), 2 descendants of its own
- K180020: HemoScreen Hematology Analyzer (2018), 2 descendants of its own
- K250943: Sysmex XR-Series (XR-10) Automated Hematology Analyzer (2025), 1 descendant of its own
- K251371: Sysmex XR-Series (XR-20) Automated Hematology Analyzer (2025), 1 descendant of its own
- K232946: Yumizen H2500 (2024), 1 descendant of its own

## Recalls of this device
- Mar 23, 2017 · Class II · Z-2034-2017: Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of sal
- Dec 18, 2014 · Class II · Z-1945-2016: There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.

## Indications for use
The XN-Series modules (XN-1O, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HOB, HCT, MCV, MCII, MCHC, FIST (PLT-I, PLT-F), NEUT%//#, LYMPH%//#, MONO%/#, EO%//#, BASO%//#, IG%//#, RDW-CV, RDW-SD, MPV, NRBC#/%, RET%/#, 11W, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN0/,/#, PMN%/#, and TC-BF parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2 or K3 EDTA 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/K112605
Methodology: https://510kreport.com/methodology