# K141681: Sysmex XN Series

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Dec 5, 2014 after 165 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (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.
No later device cites it as a predicate yet.
0 of 3 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 6.

## 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

## Indications for use
The XN-Series modules (XN-11, XN-21) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories. The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC#/%, RET%/#, 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 body fluids (peritoneal, pleural and synovial). Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid.

Source page: https://510kreport.com/device/K141681
Methodology: https://510kreport.com/methodology