# K081610: Sysmex Model XS-1000IC Automated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Aug 29, 2008 after 81 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: 1 generation back to K051459 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051459: Sysmex Model XE-2100DC Automated Hematology Analyzer, Sysmex America, Inc. (2005) Summary page 1.

## Indications for use
The Sysmex® XS-1000iC is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories and reference laboratories. The XS-1000iC will extend MCV stability to 48 hours.

Source page: https://510kreport.com/device/K081610
Methodology: https://510kreport.com/methodology