Cleared Traditional

Sysmex XR-Series (XR-20) Automated Hematology Analyzer

K251371 · Sysmex America, Inc. · Hematology
Jun 2025
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K251371 is an FDA 510(k) clearance for the Sysmex XR-Series (XR-20) Automated Hematology Analyzer, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on June 25, 2025, 54 days after receiving the submission on May 2, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K251371 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2025
Decision Date June 25, 2025
Days to Decision 54 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220

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