510(k) · Cleared
ClearedXR-Series (XR-10, XR-20) Automated Hematology Analyzers
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 May 27, 2026 as substantially equivalent to K250943 (Sysmex America, Inc., 2025) and 1 other predicate after a 240-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- May 27, 2026
- Review
- 240 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K040073 (2004). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- 3 generations backK071967 Sysmex XE-5000Sysmex America, Inc. · 2007 · Recalled
- 2 generations backK112605 Sysmex XN-SeriesSysmex America, Inc. · 2012 · Recalled
- 1 generation backK250943 Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025
- This deviceK253212 XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004 | — |
| −3 | K071967 | Sysmex XE-5000 | Sysmex America, Inc. | 2007 | 1 |
| −2 | K112605 | Sysmex XN-Series | Sysmex America, Inc. | 2012 | 2 |
| −1 | K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | 2025 | — |
| 0 (this device) | K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSummary page 6…B CELLCLEAN AUTO (Detergent) *For use with XR-20 only Predicate Device(s) and 510(k) number(s): Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943), and the Sysmex XR-Series (XR-20) Automated Hematology Analyzer (K251371). Description of the Device: The Sysmex® XR-S… | 2025 |
| * | K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSummary page 6…ate Device(s) and 510(k) number(s): Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943), and the Sysmex XR-Series (XR-20) Automated Hematology Analyzer (K251371). Description of the Device: The Sysmex® XR-Series System Configurations (XR-1500, XR-2000, XR-3000, and XR-9000) are a… | 2025 |
| † | K112605 | Sysmex XN-Series | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The XR-Series System Configurations (XR-1500, XR-2000, XR-3000 and XR-9000) are a family of integrated modular quantitative multi-parameter, automated hematology analyzer configurations intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XR Series System Configurations consist of one or more XR-Series automated hematology analyzers (XR-10 and/or XR-20) and may include an automated slide preparation…
Read the full statement (227 words)
The XR-Series System Configurations (XR-1500, XR-2000, XR-3000 and XR-9000) are a family of integrated modular quantitative multi-parameter, automated hematology analyzer configurations intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The XR Series System Configurations consist of one or more XR-Series automated hematology analyzers (XR-10 and/or XR-20) and may include an automated slide preparation unit (SP-50). The XR-2000 configuration consists of two XR-Series automated hematology analyzers (XR-10 and/or XR-20), the XR-1500/XR-3000 configurations consist of up to two XR-Series automated hematology analyzers (XR-10 and/or XR-20) and an automated slide preparation unit (SP-50), and the XR-9000 configuration consists of up to nine XR-Series automated hematology analyzers (XR-10 and/or XR-20) and an automated slide preparation unit (SP-50).
The XR-Series analyzer modules (XR-10, XR-20) classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, 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 cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA 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.
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/K253212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253212: XR-Series (XR-10, XR-20) Automated Hematology Analyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253212
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026