510(k) · Cleared
ClearedSysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L)
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 Mar 18, 2004 after a 64-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Mar 18, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- Descendant · cites it directly · 29 of its ownK071967 Sysmex XE-5000Sysmex America, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 20 of its ownK112605 Sysmex XN-SeriesSysmex America, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK091313 Sysmex Model XT-4000ISysmex America, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK190898 Sight OLOSight Diagnostics, Ltd. · 2019 · Recalled
- Descendant · 2 generations on · 2 of its ownK181288 Athelas OneAthelas, Inc. · 2018
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K071967Sysmex XE-5000Sysmex America, Inc. · 2007 · cites it directly29descendants
- K112605Sysmex XN-SeriesSysmex America, Inc. · 2012 · 2 generations on20descendants
- K091313Sysmex Model XT-4000ISysmex America, Inc. · 2010 · 2 generations on3descendants
- K190898Sight OLOSight Diagnostics, Ltd. · 2019 · 3 generations on2descendants
- K181288Athelas OneAthelas, Inc. · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K112605 | Sysmex XN-Series | Sysmex America, Inc. | 2012 | 2 |
| +2 | K091313 | Sysmex Model XT-4000I | Sysmex America, Inc. | 2010 | — |
| +3 | K190898 | Sight OLO | Sight Diagnostics, Ltd. | 2019 | 4 |
| +2 | K181288 | Athelas One | Athelas, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Manual cell counting in a counting chamber Named without a submission number |
What descends from it? (31)
See all 312 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071967 (Sysmex America, Inc., 2007) has gone furthest, with 29 descendants of its own.
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 Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Body Fluid Application adds a quantitative, automated procedure for analyzing cerebrospinal fluid, serous fluid and synovial fluid to the XE-2100 Series, providing enumeration of the WBCs and the RBCs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040073: Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040073
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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