510(k) · Cleared
Recalled · Class II · 2023Sta Compact Max
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 Feb 12, 2013 as substantially equivalent to K093167 (Diagnostica Stago, Inc., 2009) after a 29-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 12, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942117 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK942117 Sta Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1995
- 2 generations backK961579 Sta Compact Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1996 · Recalled
- 1 generation backK093167 Sta Compact Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2009 · Recalled
- This deviceK130090 Sta Compact MaxDiagnostica Stago, Incorporated · 2013
- Descendant · cites it directly · 0 of its ownK212183 STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S · 2023
Most influential descendants
Showing 1 of 1 · See all- K212183STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S · 2023 · cites it directly0descendants
View 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 | K961579 | Sta Compact Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1996 | 3 |
| −1 | K093167 | Sta Compact Automated Multi-Parametric Analyzer | Diagnostica Stago, Inc. | 2009 | 1 |
| 0 (this device) | K130090 | Sta Compact Max | Diagnostica Stago, Incorporated | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K093167 | Sta Compact Automated Multi-Parametric AnalyzerSummary page 2…ose for In Vitro Coagulation Studies Class I1 Part 864 - Hematology and Pathology Devices JPA 864.5425 Picture 1: STA Compact Max® C. Predicate Device Information K093167 STA Compactfi.Automated Multi-Parametric Analyzer STA Compact® IVD Coagulation Device/Instrument Automated and Semi-Automated He… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212183 | STA R Max 3, STA Compact Max 3 | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2023 | Class II | Z-1577-2023 | Device Design | An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K212183 (Diagnostica Stago S.A.S, 2023) has gone furthest, with 0 descendants 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. 2013, 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?
The STA Compact Max® is a fully automatic clinical analyzer 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130090: Sta Compact Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130090
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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