# K012372: Sysmex UF-50

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Sep 28, 2001 after 64 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sysmex UF-100™: named in the summary without a submission number

## Indications for use
The Sysmex UF-50 is a fully automated urine cell analyzer intended for in vitro diagnostic use in urinalysis within the clinical laboratory. The UF-50 replaces microscopic review of normal/abnormal specimens and flags specimens containing certain abnormalities which indicate the need for further testing. Iaboratorians are responsible for final microscopic review of flagged abnormalities.

Source page: https://510kreport.com/device/K012372
Methodology: https://510kreport.com/methodology