510(k) · Cleared
ClearedSTA R Max 3, STA Compact Max 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostica Stago S.A.S · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Jun 7, 2023 as substantially equivalent to K151867 (Diagnostica Stago S.A.S, 2015) and 1 other predicate after a 694-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 7, 2023
- Review
- 694 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K942117 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK942117 Sta Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1995
- 4 generations backK983460 Star Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1998 · Recalled
- 3 generations backK082675 Sta-R Evolution Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2008
- 2 generations backK093001 Sta-R Evolution Expert Series Hemostasis System Automated…Diagnostica Stago, Incorporated · 2009
- 1 generation backK151867 Sta R MaxDiagnostica Stago S.A.S · 2015 · Recalled
- This deviceK212183 STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942117 | Sta Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1995 | — |
| −4 | K983460 | Star Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1998 | 1 |
| −3 | 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 | — |
| −1 | K151867 | Sta R Max | Diagnostica Stago S.A.S | 2015 | 1 |
| 0 (this device) | K212183 | STA R Max 3, STA Compact Max 3 | Diagnostica Stago S.A.S | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K151867 | Sta R MaxSummary page 4…h aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. 3. Predicate Device Device Name: STA R Max® (K151867) / STA Compact Max® (K130090) Common Name: Automated Coagulation Analyzer Classification Name:… | 2015 |
| * | K130090 | Sta Compact MaxSummary page 4…gulation abnormalities or in monitoring anticoagulant therapy. 3. Predicate Device Device Name: STA R Max® (K151867) / STA Compact Max® (K130090) Common Name: Automated Coagulation Analyzer Classification Name: System, Multipu… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 5 of the 8 ancestors have a recall of any class.
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. 2023, 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 R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) 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/K212183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212183: STA R Max 3, STA Compact Max 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212183
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