Cleared Traditional

Sysmex XR-Series (XR-10) Automated Hematology Analyzer

K250943 · Sysmex America, Inc. · Hematology
Jun 2025
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K250943 is an FDA 510(k) clearance for the Sysmex XR-Series (XR-10) 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, 89 days after receiving the submission on March 28, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K250943 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2025
Decision Date June 25, 2025
Days to Decision 89 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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