Sysmex XR-Series (XR-20) Automated Hematology Analyzer
Summary
Sysmex America, Inc. received 510(k) clearance for Sysmex XR-Series (XR-20) Automated Hematology Analyzer, a GKZ device. Cleared on 2025-06-25.
Details
Source
510(k) Clearance
External ID
K251371
Action Date
2025-06-25
Status
Traditional
Category
device
Product Code
GKZ
Product Description
Sysmex XR-Series (XR-20) Automated Hematology Analyzer. Product code: GKZ.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Sysmex America, Inc. has received 5 total clearances in our database.
Sysmex America, Inc. has 7 FDA actions in our database, including 2 recalls and 5 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Sysmex America, Inc. have FDA actions?
Sysmex America, Inc. has 7 FDA actions in our database, including 2 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251371" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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