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The Tracker / September 2026 / K260781

510(k) cleared

Yumizen H550

HORIBA ABX SAS · Sep 14, 2026 · K260781

FDA cleared the Yumizen H550 from HORIBA ABX SAS on Sep 14, 2026 under K260781, a traditional 510(k). The device falls under product code GKZ, Counter, Differential Cell, regulated at 21 CFR 864.5220 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Mar 10, 2026. The decision came 188 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for HORIBA ABX SAS in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260781?

K260781 is the FDA 510(k) for Yumizen H550, submitted by HORIBA ABX SAS. FDA's decision date was Sep 14, 2026, under product code GKZ (Counter, Differential Cell).

Who makes the Yumizen H550?

HORIBA ABX SAS, based in Montpellier, is the applicant of record for K260781.

How long did the K260781 review take?

FDA received the submission on Mar 10, 2026 and issued its decision on Sep 14, 2026, 188 days later.

← All decisions in September 2026