# K936023: Sysmex SE-9000 Automated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Toa Medical Electronics USA, Inc.
- Decided: May 2, 1994 after 138 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964375: Sysmex SE/Ram-1 (1997), 9 descendants of its own
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer (1999), 7 descendants of its own
- K061616: Coulter LH 780 Hematology Analyzer (2006), 1 descendant of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K160429: BC-5390 Auto Hematology Analyzer (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K936023
Methodology: https://510kreport.com/methodology