510(k) · Cleared
ClearedPefakit Apc-R Factor V Leiden
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentapharm, Ltd. · GGW Test, Time, Partial Thromboplastin
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
- GGW
- 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 GGW? 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 GGW device
- #1 K260551 HemosIL Factor V Leiden (APC Resistance V)score 11.3 · 2 generations · no Class I recall
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…Predicate Device Name: COATEST'® APCTM RESISTANCE V/ COATES'rAPCTM RESISTANCE VS 510(k) Number: K963111 Regulation Number: 864.7925 Regulatory Class: II 4. Description of the dev… | 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 GGW devicesGGW Test, Time, Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGW
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GGW
Too few GGW 510(k)s in any year since 2007 to give a median.
Recalls per year · GGW
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGW
11in 2025
MAUDE reports naming product code GGW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The device is a plasma based functional assay for the determination of resistance to activated protein C caused by the factor V Leiden mutation (FV:Q506) on automated and semi-automated blood coagulation analyzers using mechanical or optical detection principle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042762: Pefakit Apc-R Factor V Leiden.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042762
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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