# K080887: Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software

- Pathway: 510(k) (Special)
- Applicant: Sysmex America, Inc.
- Decided: May 2, 2008 after 32 days
- Product code: LKM (Counter, Urine Particle)
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: 1 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 8 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)

## Most influential descendants
- K131444: UA-Cellular Complete (2014), 1 descendant of its own
- K170091: UA-Cellular Complete (2017), 0 descendants of its own
- K121456: Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control (2013), 0 descendants of its own

## Recalls of this device
- Mar 31, 2013 · Class II · Z-0949-2014: The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not prope

## Indications for use
Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i 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/K080887
Methodology: https://510kreport.com/methodology