510(k) · Cleared
ClearedVisucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Affinity Biologicals, Inc. · GGN Plasma, Coagulation Control
Cleared on Oct 20, 2011 as substantially equivalent to K082859 (Instrumentation Laboratory CO, 2008) after a 247-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 20, 2011
- Review
- 247 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002400 (2000). 11 ancestors in all, the oldest K864271 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- 2 generations backK021023 Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)Instrumentation Laboratory CO · 2002 · Recalled
- 1 generation backK082859 Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO · 2008
- This deviceK110432 Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| −2 | K021023 | Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed) | Instrumentation Laboratory CO | 2002 | 3 |
| −1 | K082859 | Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed | Instrumentation Laboratory CO | 2008 | — |
| 0 (this device) | K110432 | Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn | Affinity Biologicals, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 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? (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 |
|---|---|---|---|
| * | K082859 | Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedSummary page 1…Subpart H, Hematology Kits and Packages Product Code: GGN Predicate Device: HemoslL Routine Control Level 1, K082859 Instrumentation Laboratory Device Description: The VisuCon-F Frozen Coag Screen INis a pool… | 2008 |
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 11 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 11 ancestors have a recall of any class.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 VisuCon-F Frozen Coag Screen N plasma is an assayed normal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTI) and fibrinogen. in the normal range. The VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents. The VisuCon-F Frozen…
Read the full statement (122 words)
The VisuCon-F Frozen Coag Screen N plasma is an assayed normal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTI) and fibrinogen. in the normal range. The VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
The VisuCon-F Frozen Coag Screen ABN plasma is an assayed abnormal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated partial thromboplastin time (APTT), in the mid-level abnormal range. The VisuCon-F Frozen Coag Screen ABN plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110432: Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110432
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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