# K981950: Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Nov 3, 1998 after 153 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: 2 generations back to K912494 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964375: Sysmex SE/Ram-1, Sysmex Corp. (1997) Summary page 4.
- K912494: Sysmex (TM) R-3000 Automated Reticulocyte Analyzer, Toa Medical Electronics USA, Inc. (1991) Summary page 4.

## Indications for use
The intended use of the Sysmex R-3500 is as a fully automated reticulocyte analyzer for in vitro diagnostic use in clinical laboratories.

Source page: https://510kreport.com/device/K981950
Methodology: https://510kreport.com/methodology