# K182062: Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Oct 30, 2018 after 90 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- 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 K982301 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982301: MICRO21 with Urine Sediment Analysis, Triangle Biomedical Sciences, Inc. (1998) Summary page 4.

## Indications for use
The Sysmex® UD-10 Fully Automated Urine Particle Digital Imaging Device for locating, digitally storing and displaying microscopic images captured from urine specimens. The Sysmex® UD-10 locates and presents particles and cellular elements based on size ranges. The images are displayed for review and classification by a qualified clinical laboratory technologist on the Urinalysis Data Manager (UDM). This device is intended for in vitro diagnostic use in conjunction with a urine particle counter for screening patient populations found in clinical laboratories.

Source page: https://510kreport.com/device/K182062
Methodology: https://510kreport.com/methodology