510(k) · Cleared
Recalled · 2007Sta Compact 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 Jul 10, 1996 as substantially equivalent to K942117 (American Bioproducts Co., 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 10, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- GKP
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942117 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK942117 Sta Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1995
- This deviceK961579 Sta Compact Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. · 1996
- Descendant · cites it directly · 2 of its ownK093167 Sta Compact Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK130090 Sta Compact MaxDiagnostica Stago, Incorporated · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK212183 STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S · 2023
Most influential descendants
Showing 3 of 3 · See all- K093167Sta Compact Automated Multi-Parametric AnalyzerDiagnostica Stago, Inc. · 2009 · cites it directly2descendants
- K130090Sta Compact MaxDiagnostica Stago, Incorporated · 2013 · 2 generations on1descendant
- K212183STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.S · 2023 · 3 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) | K961579 | Sta Compact Automated Multi-Parametric Analyzer | American Bioproducts Co. | 1996 | — |
| +1 | K093167 | Sta Compact Automated Multi-Parametric Analyzer | Diagnostica Stago, Inc. | 2009 | 1 |
| +2 | K130090 | Sta Compact Max | Diagnostica Stago, Incorporated | 2013 | 1 |
| +3 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 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? (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…1% (i.e., 0.05%). The STA Compact® instrument is substantially equivalent to the commercially available full-size STA® analyzer that received FDA 510(k) clearance under K942117. | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093167 | Sta Compact Automated Multi-Parametric Analyzer | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2007 | Not classified | Z-0039-2008 | Process design | Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message. |
| Jan 18, 2007 | Not classified | Z-0812-2007 | Other | Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors. |
| 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 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 | — |
What is it indicated for?
The STA Compact® instrument is a fully automated laboratory analyzer designed to perform tests 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/K961579 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961579: Sta Compact Automated Multi-Parametric Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961579
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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