510(k) · Cleared
Recalled · Class II · 2012Sysmex XE-2100, Automatated Hematology Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex Corp. · GKZ Counter, Differential Cell
Cleared on Nov 9, 1999 as substantially equivalent to K964375 (Sysmex Corp., 1997) and 1 other predicate after a 75-day review. Its family tree reaches back 2 generations to 1991. 7 later devices descend from it. It has been recalled once.
- Decided
- Nov 9, 1999
- Review
- 75 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912494 (1991). 4 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
- 1 generation backK964375 Sysmex SE/Ram-1Sysmex Corp. · 1997
- This deviceK992875 Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp. · 1999
- Descendant · cites it directly · 1 of its ownK061616 Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · Recalled
- Descendant · cites it directly · 0 of its ownK160429 BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
- Descendant · 2 generations on · 0 of its ownK081930 Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2008 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K061616Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · cites it directly1descendant
- K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · cites it directly1descendant
- K160429BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. · 2016 · cites it directly0descendants
- K151133Pentra XLRHoriba Abx Sas · 2015 · 2 generations on0descendants
- K081930Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912494 | Sysmex (TM) R-3000 Automated Reticulocyte Analyzer | Toa Medical Electronics USA, Inc. | 1991 | — |
| −1 | K964375 | Sysmex SE/Ram-1 | Sysmex Corp. | 1997 | — |
| 0 (this device) | K992875 | Sysmex XE-2100, Automatated Hematology Analyzer | Sysmex Corp. | 1999 | — |
| +1 | K061616 | Coulter LH 780 Hematology Analyzer | Beckman Coulter, Inc. | 2006 | 7 |
| +1 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
| +1 | K160429 | BC-5390 Auto Hematology Analyzer | Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| +2 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
| +2 | K081930 | Unicel DXH 800 Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2008 | 29 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K964375 | Sysmex SE/Ram-1Summary page 3…™ Automated Hematology Analzyer XE-2100 000042 Table 1: Comparative Features to SE'/RAM-1 and SF-3000 Features XE-2100 SE/RAM-1 SF-3000 (Submission #) (K964375) (K950508) FDA Clearance --- 13-Mar-97 3-Nov-95 Intended Use Automated blood cell Automated blood celi Automated blood cell analy… | 1997 |
| * | K950508 | Sysmex SF-3000Summary page 3…d Hematology Analzyer XE-2100 000042 Table 1: Comparative Features to SE'/RAM-1 and SF-3000 Features XE-2100 SE/RAM-1 SF-3000 (Submission #) (K964375) (K950508) FDA Clearance --- 13-Mar-97 3-Nov-95 Intended Use Automated blood cell Automated blood celi Automated blood cell analyzer counte… | 1995 |
What descends from it? (7)
5 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-0254-2013 | 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K061616 (Beckman Coulter, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K964375.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in EDTA anti-coagulated blood. WBC White Blood Cells or leukocyte count Neut% Neutrophil percent Neut# Neutrophil absolute count Lymph% Lymphocyte percent Lymph# Lymphocyte absolute count Mono% Monocyte percent Mono# Monocyte absolute count Eo% Eosinophil percent Eo# Eosinophil absolute count Baso% Basophil percent Baso# Basophil absolute count…
Read the full statement (158 words)
The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in EDTA anti-coagulated blood.
WBC White Blood Cells or leukocyte count
Neut% Neutrophil percent
Neut# Neutrophil absolute count
Lymph% Lymphocyte percent
Lymph# Lymphocyte absolute count
Mono% Monocyte percent
Mono# Monocyte absolute count
Eo% Eosinophil percent
Eo# Eosinophil absolute count
Baso% Basophil percent
Baso# Basophil absolute count
NRBC% Nucleated red blood cell percent
NRBCH# Nucleated red blood cell absolute count
RBC Red Blood Cell or erythrocyte count
HGB Hemoglobin concentration
HCT Hematocrit
MCV Mean Corpuscular Volume
MCH Mean Cell Hemoglobin
MCHC Mean Cell Hemoglobin Concentration
RDW-CV Red Cell Distribution Width-Coefficient of Variation
RDW-SD Red Cell Distribution Width-Standard Deviation
RET% Reticulocyte percent
RET# Reticulocyte absolute count
IRF Immature Reticulocyte Fraction
HFR* High Fluorescent Ratio
MFR* Medium Fluorescent Ratio
LFR* Low Fluorescent Ratio
PLT Platelet count
MPV Mean Platelet Volume
PDW* Platelet Distribution Width
P-LCR* Platelet- Large Cell Ratio
PCT* Plateletcrit
*Not reportable in the USA
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992875: Sysmex XE-2100, Automatated Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992875
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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