XR-Series (XR-10, XR-20) Automated Hematology Analyzers— 510(k) K253212
Substantially EquivalentSysmex 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.. Device class: 2.
Summary
Sysmex America's XR-Series (XR-10, XR-20) Automated Hematology Analyzers are filed under GKZ, differential cell counters.
Class II, 21 CFR 864.5220. Hematology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Sysmex filed from Lincolnshire, Illinois. Review took 240 calendar days (September 29, 2025 to May 27, 2026).
Clearance details
- Applicant
- Sysmex America, Inc.
- Product code
- Product code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincolnshire, IL, US
Recent devices under product code GKZ
view allMore clearances from Sysmex America, Inc.
view all- K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- K210346 — Sysmex XW-100 Automated Hematology Analyzer
- K182389 — Sysmex XN-L Automated Hematology Analyzer
- K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . 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.