510(k) · Cleared
ClearedSF-Check
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · JPK Mixture, Hematology Quality Control
Cleared on Sep 1, 1995 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 1, 1995
- Review
- 112 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK952245 SF-CheckStreck Laboratories, Inc. · 1995
- Descendant · cites it directly · 7 of its ownK961054 Sysmex UF-100Sysmex Corp. · 1996
- Descendant · 2 generations on · 6 of its ownK070910 Sysmex Model UF1000ISysmex America, Inc. · 2007
- Descendant · 3 generations on · 3 of its ownK080887 Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis…Sysmex America, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 1 of its ownK131444 UA-Cellular CompleteStreck · 2014
- Descendant · 3 generations on · 0 of its ownK171883 Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K961054Sysmex UF-100Sysmex Corp. · 1996 · cites it directly7descendants
- K070910Sysmex Model UF1000ISysmex America, Inc. · 2007 · 2 generations on6descendants
- K080887Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareSysmex America, Inc. · 2008 · 3 generations on3descendants
- K131444UA-Cellular CompleteStreck · 2014 · 4 generations on1descendant
- K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952245 | SF-Check | Streck Laboratories, Inc. | 1995 | — |
| +1 | K961054 | Sysmex UF-100 | Sysmex Corp. | 1996 | — |
| +2 | K070910 | Sysmex Model UF1000I | Sysmex America, Inc. | 2007 | — |
| +3 | K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software | Sysmex America, Inc. | 2008 | 1 |
| +4 | K131444 | UA-Cellular Complete | Streck | 2014 | — |
| +3 | K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JPK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961054 | Sysmex UF-100 | 1996 | 7 |
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?
- Of its descendants, K961054 (Sysmex Corp., 1996) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPK
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JPK
296in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPK
2in 2023
MAUDE reports naming product code JPK, 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 | 5 | 44 | 1 | 14 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 5 | 187 | 0 | 0 |
| 2010 | 4 | 267 | 2 | 5 |
| 2011 | 1 | — | 3 | 56 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 296 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 2 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952245: SF-Check.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952245
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026