# K071967: Sysmex XE-5000

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Nov 20, 2007 after 127 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: 1 generation back to K040073 (2004). 1 ancestor in all.
29 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040073: Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L), Sysmex America, Inc. (2004) Summary page 1.

## Most influential descendants
- K112605: Sysmex XN-Series (2012), 20 descendants of its own
- K091313: Sysmex Model XT-4000I (2010), 3 descendants of its own
- K190898: Sight OLO (2019), 2 descendants of its own
- K181288: Athelas One (2018), 2 descendants of its own
- K180020: HemoScreen Hematology Analyzer (2018), 2 descendants of its own

## Recalls of this device
- Jun 1, 2012 · Class II · Z-0255-2013: There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lo

## Indications for use
Sysmex® XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 classifies and enumerates the same parameters as the XE-2100 using whole blood as described below, cord blood for HPC and has a body fluid mode for body fluids. The Body Fluid mode analyzes WBC-BF, RBC-BF, MN%/#, PMN%/f# and TC-BF in body fluids (cerebrospinal fluids (CSF), serous fluids, and synovial fluids with EDTA, as needed). WBC White Blood Cell Count RBC Red Blood Cell Count HGB Hemoglobin HCT Hematocrit MCV Mean Cell Volume MCH Mean Cell Hemoglobin MCHC Mean Cell Hemoglobin Concentration PLT Platelet Count NEUT% / # Neutrophil Percent and Count LYMPH% /# Lymphocyte Percent and Count MONO% I ft Monocyte Percent and Count EO% / # Eosinophil Percent and Count BASO% / # Basophil Percent and Count NRBC% / # Nucleated RBC Percent and Count RDWV/-SD RBC Distribution Width-SD RDW-CV RBC Distribution Width-CV MPV Mean Platelet Volume RET%/# Reticulocyte Percent and Count IRF Immature Reticulocyte IG% / f Immature Granulocyte Percent and Count HPC# Hematopoietic Progenitor Cells RET-He Reticulocyte Hemoglobin IPF Immature Platelet Fraction WBC-BF WBC count in the body fluid mode analysis. RBC-BF RBC count in the body fluid mode analysis. MN% / # Percent and number of mononuclear cells within WBC-BF. PMN%/ Percent and number of polymorphonuclear cells within WBC-BF. TC-BF# The total count including VWBC-BF and HF-BF# (the number of particles which appear in a stronger fluorescence area in DIFF scattergram)

Source page: https://510kreport.com/device/K071967
Methodology: https://510kreport.com/methodology