510(k) · Cleared
ClearedSta Automated Multi-Parametric Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bioproducts Co. · GKP Instrument, Coagulation, Automated
Cleared on Feb 1, 1995 after a 274-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Feb 1, 1995
- Review
- 274 days
- Class
- Class II
- Product code
- GKP
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK942117 Sta Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1995
- Descendant · cites it directly · 6 of its ownK983460 Star Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1998 · Recalled
- Descendant · 2 generations on · 3 of its ownK082675 Sta-R Evolution Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK961579 Sta Compact Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1996 · Recalled
- Descendant · 2 generations on · 2 of its ownK093167 Sta Compact Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 2 of its ownK093001 Sta-R Evolution Expert Series Hemostasis System Automated…Diagnostica Stago, Incorporated · 2009
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K983460Star Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1998 · cites it directly6descendants
- K082675Sta-R Evolution Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2008 · 2 generations on3descendants
- K961579Sta Compact Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1996 · cites it directly3descendants
- K093167Sta Compact Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2009 · 2 generations on2descendants
- K093001Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric AnalyzerDiagnostica Stago, Incorporated · 2009 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942117 | Sta Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1995 | — |
| +1 | K983460 | Star Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1998 | 1 |
| +2 | K082675 | Sta-R Evolution Automated Multi-Parametric Analyzer | Diagnostica Stago, Inc. | 2008 | — |
| +1 | K961579 | Sta Compact Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1996 | 3 |
| +2 | K093167 | Sta Compact Automated Multi-Parametric Analyzer | Diagnostica Stago, Inc. | 2009 | 1 |
| +3 | K093001 | Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric… | Diagnostica Stago, Incorporated | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKP? 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 GKP device
- #1 K242127 ACL TOP Family 50 Series (ACL TOP 750; ACL TOP…score 9.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983460 (American Bioproducts Co., 1998) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GKP devicesGKP Instrument, Coagulation, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GKP
Too few GKP 510(k)s in any year since 2007 to give a median.
Recalls per year · GKP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKP
5in 2024
MAUDE reports naming product code GKP, 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 | — | 3 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 190 |
| 2010 | 0 | — | 4 | 74 |
| 2011 | 0 | — | 0 | 45 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 24 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 38 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K942117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942117: Sta 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/K942117
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026