510(k) · Cleared
ClearedSysmex UF-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex Corp. · LKM Counter, Urine Particle
Cleared on Oct 28, 1996 as substantially equivalent to K900484 (Streck Laboratories, Inc., 1990) and 1 other predicate after a 224-day review. Its family tree reaches back 1 generation to 1990. 7 later devices descend from it.
- Decided
- Oct 28, 1996
- Review
- 224 days
- Class
- Class II
- Product code
- LKM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900484 (1990). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK900484 Ret-CheckStreck Laboratories, Inc. · 1990
- This deviceK961054 Sysmex UF-100Sysmex Corp. · 1996
- Descendant · cites it directly · 6 of its ownK070910 Sysmex Model UF1000ISysmex America, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK080887 Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis…Sysmex America, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK131444 UA-Cellular CompleteStreck · 2014
- Descendant · 2 generations on · 0 of its ownK171883 Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK170091 UA-Cellular CompleteStreck · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K070910Sysmex Model UF1000ISysmex America, Inc. · 2007 · cites it directly6descendants
- K080887Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareSysmex America, Inc. · 2008 · 2 generations on3descendants
- K131444UA-Cellular CompleteStreck · 2014 · 3 generations on1descendant
- K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc. · 2018 · 2 generations on0descendants
- K170091UA-Cellular CompleteStreck · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900484 | Ret-Check | Streck Laboratories, Inc. | 1990 | — |
| 0 (this device) | K961054 | Sysmex UF-100 | Sysmex Corp. | 1996 | — |
| +1 | K070910 | Sysmex Model UF1000I | Sysmex America, Inc. | 2007 | — |
| +2 | K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software | Sysmex America, Inc. | 2008 | 1 |
| +3 | K131444 | UA-Cellular Complete | Streck | 2014 | — |
| +2 | K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. | 2018 | — |
| +4 | K170091 | UA-Cellular Complete | Streck | 2017 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K900484 | Ret-CheckSummary page 1…1996 Names of Device: Trade Name: UF-Check Common Name: Assayed Urinalysis Control Classification Name: Urinalysis quality control mixture Predicate Device: Ret-Check (K900484) SF-Check (K952245) Description: UF-Check is a suspension of particles representing red blood cells, white blood cells, epitheli… | 1990 |
| * | K952245 | SF-CheckSummary page 1…ce: Trade Name: UF-Check Common Name: Assayed Urinalysis Control Classification Name: Urinalysis quality control mixture Predicate Device: Ret-Check (K900484) SF-Check (K952245) Description: UF-Check is a suspension of particles representing red blood cells, white blood cells, epithelial cells, casts, an… | 1995 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070910 | Sysmex Model UF1000I | 2007 | 6 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K070910 (Sysmex America, Inc., 2007) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LKM devicesLKM Counter, Urine Particle: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961054: Sysmex UF-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961054
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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