# K083002: Sysmex UF-500I Automated Urine Particle Analyzer

- Pathway: 510(k) (Special)
- Applicant: Sysmex America, Inc.
- Decided: Feb 3, 2009 after 118 days
- Product code: LKM (Counter, Urine Particle)
- 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: 3 generations back to K900484 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070910: Sysmex Model UF1000I, Sysmex America, Inc. (2007)

## Indications for use
The Sysmex® UF-500i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-500i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.

Source page: https://510kreport.com/device/K083002
Methodology: https://510kreport.com/methodology