Cleared Traditional

K250943 - Sysmex XR-Series (XR-10) Automated Hematology Analyzer (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K250943 is an FDA 510(k) clearance for the Sysmex XR-Series (XR-10) Automated Hematology Analyzer. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on June 25, 2025 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sysmex America, Inc. devices

Submission Details

510(k) Number K250943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 113d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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