510(k) · Cleared
Recalled · 2003Star Automated Multi-Parametric Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bioproducts Co. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Nov 12, 1998 as substantially equivalent to K942117 (American Bioproducts Co., 1995) after a 43-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it. It has been recalled once.
- Decided
- Nov 12, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942117 (1995). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942117 Sta Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1995
- This deviceK983460 Star Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1998
- Descendant · cites it directly · 3 of its ownK082675 Sta-R Evolution Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK093001 Sta-R Evolution Expert Series Hemostasis System Automated…Diagnostica Stago, Incorporated · 2009
- Descendant · 3 generations on · 1 of its ownK151867 Sta R MaxDiagnostica Stago S.A.S · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK082248 Sta Satellite Automated Multi-Parameter AnalyzerDiagnostica Stago, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK253658 STA Satellite Max®Diagnostica Stago, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082675Sta-R Evolution Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2008 · cites it directly3descendants
- K093001Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric AnalyzerDiagnostica Stago, Incorporated · 2009 · 2 generations on2descendants
- K151867Sta R MaxDiagnostica Stago S.A.S · 2015 · 3 generations on1descendant
- K082248Sta Satellite Automated Multi-Parameter AnalyzerDiagnostica Stago, Inc. · 2008 · cites it directly1descendant
- K253658STA Satellite Max®Diagnostica Stago, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942117 | Sta Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1995 | — |
| 0 (this device) | K983460 | Star Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1998 | — |
| +1 | K082675 | Sta-R Evolution Automated Multi-Parametric Analyzer | Diagnostica Stago, Inc. | 2008 | — |
| +2 | K093001 | Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric… | Diagnostica Stago, Incorporated | 2009 | — |
| +3 | K151867 | Sta R Max | Diagnostica Stago S.A.S | 2015 | 1 |
| +1 | K082248 | Sta Satellite Automated Multi-Parameter Analyzer | Diagnostica Stago, Inc. | 2008 | 2 |
| +2 | K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K942117 | Sta Automated Multi-Parametric AnalyzerSummary page 1…ubstantially equivalent to the commercially available STA® analyzer, also from the same manufacturer (Diagnostica Stago, France), that received 510(k) clearance . under K942117. % of WEALTH 4 SERVICg o g » s 3 %, Wygan « DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Foo… | 1995 |
What descends from it? (6)
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 5, 2003 | Not classified | Z-0899-03 | Other | With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument designed for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
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/K983460 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983460: Star Automated Multi-Parametric Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983460
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