# K961054: Sysmex UF-100

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Oct 28, 1996 after 224 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: 1 generation back to K900484 (1990). 2 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K900484: Ret-Check, Streck Laboratories, Inc. (1990) Summary page 1.
- K952245: SF-Check, Streck Laboratories, Inc. (1995) Summary page 1.

## Most influential descendants
- K070910: Sysmex Model UF1000I (2007), 6 descendants of its own
- 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

## Indications for use
UF-Check™ is intended for use in the quality control of Sysmex UF-100™ automated urine analyzer. The Sysmex UF-100 is a in vitro medical device for use in urinalysis in clinical laboratories to replace microscopic review of normal and abnormal specimens and to flag specimens containing certain abnormalities.

Source page: https://510kreport.com/device/K961054
Methodology: https://510kreport.com/methodology