510(k) · Cleared
Recalled · Class II · 2025Sta Satellite Automated Multi-Parameter Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostica Stago, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Dec 12, 2008 as substantially equivalent to K983460 (American Bioproducts Co., 1998) and 1 other predicate after a 126-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 12, 2008
- Review
- 126 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K942117 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK942117 Sta Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1995
- 1 generation backK983460 Star Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1998 · Recalled
- This deviceK082248 Sta Satellite Automated Multi-Parameter AnalyzerDiagnostica Stago, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK253658 STA Satellite Max®Diagnostica Stago, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253658STA Satellite Max®Diagnostica Stago, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942117 | Sta Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1995 | — |
| −1 | K983460 | Star Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1998 | 1 |
| 0 (this device) | K082248 | Sta Satellite Automated Multi-Parameter Analyzer | Diagnostica Stago, Inc. | 2008 | — |
| +1 | K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K983460 | Star Automated Multi-Parametric AnalyzerSummary page 1…System, Multipurpose for In Vitro Coagulation Studies Predicate Devices: * Diagnostica Stago SAS' STA-R®Automated Multi-Parametric Analyzer (K983460). * Sigma Diagnostic Inc.'s AMAX Destiny Coagulation Analyzer (K021162). File: DSI-Satellite-Attachment-06v4-510(k)… | 1998 |
| * | K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny…Summary page 1…* Diagnostica Stago SAS' STA-R®Automated Multi-Parametric Analyzer (K983460). * Sigma Diagnostic Inc.'s AMAX Destiny Coagulation Analyzer (K021162). File: DSI-Satellite-Attachment-06v4-510(k)Summary.doc Page 1 of 3… | 2002 |
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 |
|---|---|---|---|
| K253658 | STA Satellite Max® | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2025 | Class II | Z-2473-2025 | Mixed-up of materials/components | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| Jun 15, 2012 | Class II | Z-0252-2013 | Software design | Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K253658 (Diagnostica Stago, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K983460.
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. 2008, 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 SatelliteTM 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 as stated in the FDA summary.
https://510kreport.com/device/K082248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082248: Sta Satellite Automated Multi-Parameter Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082248
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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