# K260781: Yumizen H550

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Sep 14, 2026 after 188 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K040073 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232946: Yumizen H2500, Horiba Abx Sas (2024) Summary page 15.

## Indications for use
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

Source page: https://510kreport.com/device/K260781
Methodology: https://510kreport.com/methodology