XR-Series (XR-10, XR-20) Automated Hematology Analyzers— 510(k) K253212

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K253212 for XR-Series (XR-10, XR-20) Automated Hematology Analyzers, Substantially Equivalent on 2026-05-27. Applicant: Sysmex America, Inc..

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2025-09-29
Decision date: 2026-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.