# K021241: Sysmex XT-Series, Model XT-2000I and XT-1800I

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corporation of America
- Decided: Jun 25, 2002 after 67 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912494 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer, Sysmex Corp. (1999) Summary page 2.

## Indications for use
The SysmexB XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer.

Source page: https://510kreport.com/device/K021241
Methodology: https://510kreport.com/methodology