510(k) · Cleared
ClearedSysmex UF-500I Automated Urine Particle Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex America, Inc. · LKM Counter, Urine Particle
Cleared on Feb 3, 2009 as substantially equivalent to K070910 (Sysmex America, Inc., 2007) after a 118-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Feb 3, 2009
- Review
- 118 days
- Class
- Class II
- Product code
- LKM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900484 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900484 | Ret-Check | Streck Laboratories, Inc. | 1990 | — |
| −2 | K961054 | Sysmex UF-100 | Sysmex Corp. | 1996 | — |
| −1 | K070910 | Sysmex Model UF1000I | Sysmex America, Inc. | 2007 | — |
| 0 (this device) | K083002 | Sysmex UF-500I Automated Urine Particle Analyzer | Sysmex America, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKM device
- #1 K252580 iQ200 Seriesscore 9.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070910 | Sysmex Model UF1000I | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K070910.
How does its category compare?
All LKM devicesLKM Counter, Urine Particle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LKM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKM
Too few LKM 510(k)s in any year since 2007 to give a median.
Recalls per year · LKM
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKM
1in 2021
MAUDE reports naming product code LKM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 4 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sysmex® UF-500i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-500i 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083002: Sysmex UF-500I Automated Urine Particle Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083002
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026