510(k) · Cleared
ClearedSta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostica Stago, Incorporated · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Dec 18, 2009 as substantially equivalent to K082675 (Diagnostica Stago, Inc., 2008) after an 81-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 18, 2009
- Review
- 81 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942117 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK942117 Sta Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1995
- 2 generations backK983460 Star Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1998 · Recalled
- 1 generation backK082675 Sta-R Evolution Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2008
- This deviceK093001 Sta-R Evolution Expert Series Hemostasis System Automated…Diagnostica Stago, Incorporated · 2009
- Descendant · cites it directly · 1 of its ownK151867 Sta R MaxDiagnostica Stago S.A.S · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK212183 STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942117 | Sta Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1995 | — |
| −2 | K983460 | Star Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1998 | 1 |
| −1 | K082675 | Sta-R Evolution Automated Multi-Parametric Analyzer | Diagnostica Stago, Inc. | 2008 | — |
| 0 (this device) | K093001 | Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric… | Diagnostica Stago, Incorporated | 2009 | — |
| +1 | K151867 | Sta R Max | Diagnostica Stago S.A.S | 2015 | 1 |
| +2 | K212183 | STA R Max 3, STA Compact Max 3 | Diagnostica Stago S.A.S | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 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 JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 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 |
|---|---|---|---|
| * | K082675 | Sta-R Evolution Automated Multi-Parametric AnalyzerSummary page 1…ro Coagulation Studies Predicate Device: Diagnostica Stago's STA-R Evolution®0 Expert Series Automated Multi-Parametric Analyzer (K082675). Purpose of the Special 510(k) Notice: The STA-R Evolution® Expert Series Hemostasis System is a modif… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151867 | Sta R Max | 2015 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K151867 (Diagnostica Stago S.A.S, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
STA-R Evolution® Expert Series Hemostasis System is a frully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093001: Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093001
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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