# K070910: Sysmex Model UF1000I

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: May 25, 2007 after 53 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: 2 generations back to K900484 (1990). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961054: Sysmex UF-100, Sysmex Corp. (1996) Summary page 1.

## Most influential descendants
- K080887: Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software (2008), 3 descendants of its own
- K131444: UA-Cellular Complete (2014), 1 descendant of its own
- K171883: Sysmex  UF-5000 Fully Automated Urine Particle Analyzer (2018), 0 descendants 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

## 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/K070910
Methodology: https://510kreport.com/methodology