510(k) · Cleared
ClearedVital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag Coagulation Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Scientific N.V. · GGN Plasma, Coagulation Control
Cleared on Jul 23, 2002 as substantially equivalent to K952622 (Precision Biologicals, Inc., 1995) and 2 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 23, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931117 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK931117 Assess (TM) Low Abnormal ControlInstrumentation Laboratory CO · 1994
- This deviceK022046 Vital Scientific Coagulation Control,Coagulation Control Level…Vital Scientific N.V. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931117 | Assess (TM) Low Abnormal Control | Instrumentation Laboratory CO | 1994 | — |
| 0 (this device) | K022046 | Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag… | Vital Scientific N.V. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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 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? (3)
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 |
|---|---|---|---|
| * | K952622 | Cryo Check Normal Human Reference Plasma Our reading of the summary gave K952662, FDA’s number for Comp=Flow (Jeneric/Pentron, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Precision Biologic Pooled Normal Plasma”. | 1995 |
| * | K931117 | Assess (TM) Low Abnormal ControlSummary page 2…mpared to Precision Biologic Pooled Normal Plasma (K952662). The Coagulation Control 2 was compared with the Assess Low Abnormal Control from Instrumentation laboratory (K931117). The Coagulation Control 3 was compared with the Assess High Abnormal Control from Instrumentation Laboratory (K931118) on the M… | 1994 |
| * | K931118 | Assess (TM) High Abnormal ControlSummary page 2…Abnormal Control from Instrumentation laboratory (K931117). The Coagulation Control 3 was compared with the Assess High Abnormal Control from Instrumentation Laboratory (K931118) on the MLA-9OOC Coagulometer (K884863). Within-run precision studies were performed and yielded substantially equivalent data a… | 1994 |
| † | K884863 | Electra 900C Automatic Coagulation Timer | 1989 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K952622.
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 | — |
What is it indicated for?
The Coagulation Controls Levels 1, 2, and 3 are in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APPT). Level Iyields result in the normal range. Level 2 yields results in the moderately abnormal range. Level 3 is intended to yield results in the extremely abnormal range.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022046: Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag Coagulation Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022046
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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