510(k) · Cleared
Recalled · Class II · 2012Sysmex XE-5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex America, Inc. · GKZ Counter, Differential Cell
Cleared on Nov 20, 2007 as substantially equivalent to K040073 (Sysmex America, Inc., 2004) after a 127-day review. Its family tree reaches back 1 generation to 2004. 29 later devices descend from it. It has been recalled once.
- Decided
- Nov 20, 2007
- Review
- 127 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040073 (2004). 29 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- This deviceK071967 Sysmex XE-5000Sysmex America, Inc. · 2007
- Descendant · cites it directly · 20 of its ownK112605 Sysmex XN-SeriesSysmex America, Inc. · 2012 · Recalled
- Descendant · cites it directly · 3 of its ownK091313 Sysmex Model XT-4000ISysmex America, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK190898 Sight OLOSight Diagnostics, Ltd. · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK181288 Athelas OneAthelas, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK180020 HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. · 2018
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K112605Sysmex XN-SeriesSysmex America, Inc. · 2012 · cites it directly20descendants
- K091313Sysmex Model XT-4000ISysmex America, Inc. · 2010 · cites it directly3descendants
- K190898Sight OLOSight Diagnostics, Ltd. · 2019 · 2 generations on2descendants
- K181288Athelas OneAthelas, Inc. · 2018 · cites it directly2descendants
- K180020HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004 | — |
| 0 (this device) | K071967 | Sysmex XE-5000 | Sysmex America, Inc. | 2007 | — |
| +1 | K112605 | Sysmex XN-Series | Sysmex America, Inc. | 2012 | 2 |
| +1 | K091313 | Sysmex Model XT-4000I | Sysmex America, Inc. | 2010 | — |
| +2 | K190898 | Sight OLO | Sight Diagnostics, Ltd. | 2019 | 4 |
| +1 | K181288 | Athelas One | Athelas, Inc. | 2018 | — |
| +2 | K180020 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L)Summary page 1…Option: Graphic printer Bar code Reader 3. Predicate Method: Sysmex® XE-2100 Body Fluid (K040073-Cleared March 18, 2004) 4. Device The Sysmex ® XE-5000 is part of the XE-Series instrument line. It is a Descripti… | 2004 |
| † | K992875 | Sysmex XE-2100, Automatated Hematology Analyzer | 1999 |
| † | K020496 | HPC (Hematopoietic Progenitor Cell) Parameter on the Imi Channel of the Sysmex SE-9500… | 2002 |
| † | K032039 | Immature Granulocyte (IG) Parameter on the Sysmex Model XE-2100 Automated Hematology… | 2003 |
| † | K050589 | Ret-HE Parameter on the Sysmex Model XE-2100 Automated Hematology Analyzer | 2005 |
| † | K051199 | Ipf (Immature Platelet Fraction) Parameter on the Sysmex Model XE-2100 Automated… | 2005 |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2012 | Class II | Z-0255-2013 | Device Design | 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% lower on the XE-Series because of a low… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
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…
Read the full statement (247 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071967: Sysmex XE-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071967
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026