510(k) · Cleared
ClearedYumizen H550
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx Sas · GKZ Counter, Differential Cell
Cleared on Sep 14, 2026 as substantially equivalent to K232946 (Horiba Abx Sas, 2024) after a 188-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Sep 14, 2026
- Review
- 188 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040073 (2004). 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 backK232946 Yumizen H2500Horiba Abx Sas · 2024
- This deviceK260781 Yumizen H550Horiba Abx Sas · 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 | K232946 | Yumizen H2500 | Horiba Abx Sas | 2024 | — |
| 0 (this device) | K260781 | Yumizen H550 | Horiba Abx Sas | 2026 | — |
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 |
|---|---|---|---|
| * | K232946 | Yumizen H2500Summary page 15…n K260781 V. Substantial Equivalence Information A. Predicate Device Name(s) Yumizen H2500 B. Predicate 510(k) Number(s) K232946 C. Comparison with Predicate Table 2 - Comparison with predicate Device & Predicate K2607… | 2024 |
| † | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | 2005 |
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 2 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 4 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?
Yumizen H550 analyzers classify and enumerate the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, BAS%, IMG#, IMG%. Yumizen H550 analyzers provide information for in vitro diagnostic use in clinical laboratories. Yumizen H550 analyzers are used for screening a physiological state (quantitative or qualitative hematology abnormality detection) or a…
Read the full statement (163 words)
Yumizen H550 analyzers classify and enumerate the following parameters in whole blood:
WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, BAS%, IMG#, IMG%.
Yumizen H550 analyzers provide information for in vitro diagnostic use in clinical laboratories.
Yumizen H550 analyzers are used for screening a physiological state (quantitative or qualitative hematology abnormality detection) or a pathological state of patient populations found in clinical laboratories.
Yumizen H550 analyzer are quantitative for parameters measurement and qualitative for alarms detection.
Yumizen H550 analyzers are intended to perform tests on the following specimens:
■ Venous blood
■ Capillary blood
collected in K2-EDTA and K3-EDTA anticoagulant.
Yumizen H550 analyzers are intended to perform tests on the following specimens:
Pediatric
■ New born: from birth to 28 days
■ Infant: from 29 days to 2 years
■ Children: from 2 years to 12 years
■ Adolescent: from 12 years to 21 years
Adult population
■ Above 21 years
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/K260781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260781: Yumizen H550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260781
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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