510(k) · Cleared
Recalled · Class II · 2017Sysmex XN-Series
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 Oct 19, 2012 as substantially equivalent to K071967 (Sysmex America, Inc., 2007) after a 408-day review. Its family tree reaches back 2 generations to 2004. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 19, 2012
- Review
- 408 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040073 (2004). 20 later devices descend from it, 13 citing it directly.
- Root · 2 generations backK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- 1 generation backK071967 Sysmex XE-5000Sysmex America, Inc. · 2007 · Recalled
- This deviceK112605 Sysmex XN-SeriesSysmex America, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK190898 Sight OLOSight Diagnostics, Ltd. · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK180020 HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK250943 Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK251371 Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK232946 Yumizen H2500Horiba Abx Sas · 2024
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K190898Sight OLOSight Diagnostics, Ltd. · 2019 · cites it directly2descendants
- K180020HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. · 2018 · cites it directly2descendants
- K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025 · cites it directly1descendant
- K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc. · 2025 · cites it directly1descendant
- K232946Yumizen H2500Horiba Abx Sas · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004 | — |
| −1 | K071967 | Sysmex XE-5000 | Sysmex America, Inc. | 2007 | 1 |
| 0 (this device) | K112605 | Sysmex XN-Series | Sysmex America, Inc. | 2012 | — |
| +1 | K190898 | Sight OLO | Sight Diagnostics, Ltd. | 2019 | 4 |
| +1 | K180020 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2018 | — |
| +1 | K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | 2025 | — |
| +1 | K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | 2025 | — |
| +1 | K232946 | Yumizen H2500 | Horiba Abx Sas | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K071967 | Sysmex XE-5000Summary page 4…XE-5000. IXE-5000. Predicate XE-5000 XN-Series Item (K(071967) (XN-1O, XN-2O) _______________XN-10… | 2007 |
What descends from it? (20)
See all 2013 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190898 | Sight OLO | 2019 | 2 |
| K180020 | HemoScreen Hematology Analyzer | 2018 | 2 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | 2025 | 1 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | 2025 | 1 |
| K232946 | Yumizen H2500 | 2024 | 1 |
| K220031 | Alinity h-series System | 2023 | 1 |
| K240402 | Cito CBC System | 2025 | 0 |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | 2023 | 0 |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | 2019 | 0 |
| K171655 | cobas m 511 integrated hematology analyzer | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2017 | Class II | Z-2034-2017 | Component design/selection | 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 salt deposits on unprotected electronic… |
| Dec 18, 2014 | Class II | Z-1945-2016 | Device Design | There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K190898 (Sight Diagnostics, Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K071967.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 XN-Series modules (XN-1O, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HOB, HCT, MCV, MCII, MCHC, FIST (PLT-I, PLT-F), NEUT%//#, LYMPH%//#, MONO%/#, EO%//#, BASO%//#, IG%//#, RDW-CV, RDW-SD, MPV, NRBC#/%, RET%/#, 11W, IRF, RET-He…
Read the full statement (130 words)
The XN-Series modules (XN-1O, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The XN-Series modules classify and enumerate the following parameters in whole blood: WBC, RBC, HOB, HCT, MCV, MCII, MCHC, FIST (PLT-I, PLT-F), NEUT%//#, LYMPH%//#, MONO%/#, EO%//#, BASO%//#, IG%//#, RDW-CV, RDW-SD, MPV, NRBC#/%, RET%/#, 11W, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN0/,/#, PMN%/#, and TC-BF parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2 or K3 EDTA 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/K112605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112605: Sysmex XN-Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112605
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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