510(k) · Cleared
Recalled · Class II · 2013Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software
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 May 2, 2008 as substantially equivalent to K070910 (Sysmex America, Inc., 2007) after a 32-day review. Its family tree reaches back 3 generations to 1990. 3 later devices descend from it. It has been recalled once.
- Decided
- May 2, 2008
- Review
- 32 days
- Class
- Class II
- Product code
- LKM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900484 (1990). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK900484 Ret-CheckStreck Laboratories, Inc. · 1990
- 2 generations backK961054 Sysmex UF-100Sysmex Corp. · 1996
- 1 generation backK070910 Sysmex Model UF1000ISysmex America, Inc. · 2007
- This deviceK080887 Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis…Sysmex America, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK131444 UA-Cellular CompleteStreck · 2014
- Descendant · 2 generations on · 0 of its ownK170091 UA-Cellular CompleteStreck · 2017
- Descendant · cites it directly · 0 of its ownK121456 Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer…Arkray, Inc. · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See allView 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) | K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software | Sysmex America, Inc. | 2008 | — |
| +1 | K131444 | UA-Cellular Complete | Streck | 2014 | — |
| +2 | K170091 | UA-Cellular Complete | Streck | 2017 | — |
| +1 | K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System… | Arkray, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2013 | Class II | Z-0949-2014 | Software design | The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LKM devicesLKM Counter, Urine Particle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080887: Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080887
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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