510(k) · Cleared
ClearedXW-100 Automated Hematology Analyzer for CLIA Waived Use
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 6, 2017 as substantially equivalent to K143577 (Sysmex America, Inc., 2015) after a 68-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Nov 6, 2017
- Review
- 68 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852992 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK852992 Para Check (Aka Eight Check-C)Streck Laboratories, Inc. · 1985
- 1 generation backK143577 XW-100 Automated Hematology Analyzer, XW QC CHECKSysmex America, Inc. · 2015
- This deviceK172604 XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK210346 Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K210346Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852992 | Para Check (Aka Eight Check-C) | Streck Laboratories, Inc. | 1985 | — |
| −1 | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | Sysmex America, Inc. | 2015 | — |
| 0 (this device) | K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | Sysmex America, Inc. | 2017 | — |
| +1 | K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECKSummary page 5…Sysmex XW-100 Automated Hematology Analyzer for Point of Care Use. 6. Clinical performance data Please reference k143577 for clinical performance data and CW170004 for clinical field data and flex studies. 7. Conclu… | 2015 |
| † | K943268 | SCS-1000 (Sysmex Calibrator System) | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | 2022 | 0 |
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 32 years and passes through 2 companies; a new generation was cleared every 30.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210346 (Sysmex America, Inc., 2022) has gone furthest, with 0 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. 2017, 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/K172604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172604: XW-100 Automated Hematology Analyzer for CLIA Waived Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172604
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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