510(k) · Cleared
Recalled · Class II · 2019Sta System Control [N] + [P] Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bioproducts Co. · GGN Plasma, Coagulation Control
Cleared on Mar 21, 1995 after a 243-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 21, 1995
- Review
- 243 days
- Class
- Class II
- Product code
- GGN
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK943518 Sta System Control [N] + [P] KitAmerican Bioproducts Co. · 1995
- Descendant · cites it directly · 0 of its ownK120014 Sta- Coag Control (N+Abn) PlusDiagnostica Stago, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K120014Sta- Coag Control (N+Abn) PlusDiagnostica Stago, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943518 | Sta System Control [N] + [P] Kit | American Bioproducts Co. | 1995 | — |
| +1 | K120014 | Sta- Coag Control (N+Abn) Plus | Diagnostica Stago, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 GGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120014 | Sta- Coag Control (N+Abn) Plus | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2019 | Class II | Z-0738-2020 | Process control | A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several… |
| Aug 23, 2011 | Not classified | Z-1044-2012 | Nonconforming Material/Component | Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120014 (Diagnostica Stago, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGN
4in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · GGN
96in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGN
4in 2018
MAUDE reports naming product code GGN, 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 | 3 | 47 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 37 |
| 2010 | 3 | 23 | 4 | 17 |
| 2011 | 2 | — | 1 | 30 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 3 | 441 | 3 | 9 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 96 | 0 | 11 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K943518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K943518: Sta System Control [N] + [P] Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943518
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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