# K091313: Sysmex Model XT-4000I

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Mar 30, 2010 after 330 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: 2 generations back to K040073 (2004). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071967: Sysmex XE-5000, Sysmex America, Inc. (2007) Summary page 2.

## Cited in the summary but kept off the family tree
- K021241: Sysmex XT-Series, Model XT-2000I and XT-1800I, Sysmex Corporation of America (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K091539: IQ 200 Urine Analizer Body Fluids Module (2010), 2 descendants of its own
- K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System (2021), 1 descendant of its own
- K252580: iQ200 Series (2025), 0 descendants of its own

## Indications for use
The Sysmex® XT-4000i is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XT-4000i classifies and enumerates the following parameters for whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, RET%/#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/# and TC-BF# parameters in cerebrospinal fluids (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Serous and Synovial fluids should be collected in K2EDTA to prevent clotting of fluid. The use of anticoagulants with CSF specimens is not required or recommended.

Source page: https://510kreport.com/device/K091313
Methodology: https://510kreport.com/methodology