510(k) · Cleared
ClearedPefakit Apc-R Factor V Leiden Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentapharm, Ltd. · GGN Plasma, Coagulation Control
Cleared on Dec 22, 2004 as substantially equivalent to K963111 (Chromogenix AB, 1996) after a 78-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 22, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945940 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SSummary page 1…edicate Device Name: COATEST® APCTM RESISTANCE V/ COATEST® APCTM RESISTANCE VS 510(k) Number: K963111 Regulation Number: 864.7925 Regulatory Class: II 4. Description of the d… | 1996 |
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 9 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K963111.
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 device is a box containing lyophilized pooled plasmas from donors genotyped for the factor V Leiden mutation (FV: Q506) to be reconstituted with water by the user. Controls contain pooled plasmas of either donors with heterozygous FV:Q506 mutation or normal wild-type pattern. These controls are intended to be used for quality assurance in connection with the IVD device 'Pefakit® APC-R Factor V Leiden'.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042760: Pefakit Apc-R Factor V Leiden Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042760
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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