# K981761: Sysmex KX-21, Automated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Aug 14, 1998 after 87 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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 K882370 (1988). 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)
- K882370: Sysmex K-1000 18 Parameter, Auto. Hema Analyzer, Toa Medical Electronics USA, Inc. (1988) Summary page 2.

## Indications for use
The intended use of the Sysmex KX-21 is as an automated cell counter for in vitro diagnostic use in clinical laboratories.

Source page: https://510kreport.com/device/K981761
Methodology: https://510kreport.com/methodology