# K040073: Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L)

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Mar 18, 2004 after 64 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
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Manual cell counting in a counting chamber: named in the summary without a submission number

## Most influential descendants
- K071967: Sysmex XE-5000 (2007), 29 descendants of its own
- K112605: Sysmex XN-Series (2012), 20 descendants of its own
- K091313: Sysmex Model XT-4000I (2010), 3 descendants of its own
- K190898: Sight OLO (2019), 2 descendants of its own
- K181288: Athelas One (2018), 2 descendants of its own

## Indications for use
The Sysmex® XE-2100 Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Body Fluid Application adds a quantitative, automated procedure for analyzing cerebrospinal fluid, serous fluid and synovial fluid to the XE-2100 Series, providing enumeration of the WBCs and the RBCs.

Source page: https://510kreport.com/device/K040073
Methodology: https://510kreport.com/methodology