510(k) · Cleared
ClearedSysmex XW-100 Automated Hematology Analyzer
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 8, 2022 as substantially equivalent to K172604 (Sysmex America, Inc., 2017) after a 638-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Nov 8, 2022
- Review
- 638 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K852992 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK852992 Para Check (Aka Eight Check-C)Streck Laboratories, Inc. · 1985
- 2 generations backK143577 XW-100 Automated Hematology Analyzer, XW QC CHECKSysmex America, Inc. · 2015
- 1 generation backK172604 XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc. · 2017
- This deviceK210346 Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852992 | Para Check (Aka Eight Check-C) | Streck Laboratories, Inc. | 1985 | — |
| −2 | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | Sysmex America, Inc. | 2015 | — |
| −1 | K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | Sysmex America, Inc. | 2017 | — |
| 0 (this device) | K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived UseSummary page 4…21 CFR 864.5220 Device Class: 2 Product Code: GKZ Predicate Device/510(k): XW-100 Automated Hematology Analyzer for CLIA Waived Use K172604, dual submission CLIA Waiver by Application CW170012 Sysmex America, Inc. XW-100 Automated Hematology Analyzer for CLIA Wai… | 2017 |
| † | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | 2015 |
| † | K943268 | SCS-1000 (Sysmex Calibrator System) | 1994 |
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 37 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for
in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with
K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and
NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/
disorders, oncology patients, critically ill patients, or children under the age of 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210346: Sysmex XW-100 Automated Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210346
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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