Cleared Traditional

K232946 - Yumizen H2500

K232946 is an FDA 510(k) clearance for Yumizen H2500, manufactured by HORIBA ABX SAS. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K232946 · HORIBA ABX SAS · Hematology device
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Optimized for regulatory review, auditing and printing
May 2024
Decision
244d
Days
Class 2
Risk

K232946 is an FDA 510(k) clearance for the Yumizen H2500. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on May 21, 2024 after a review of 244 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all HORIBA ABX SAS devices

FDA 510(k) Submission Details - K232946

510(k) Number K232946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2023
Decision Date May 21, 2024
Days to Decision 244 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 113d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 226
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K232946.
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