510(k) · Cleared
ClearedCoatest Factor Viii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kabivitrum, Inc. · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Jan 30, 1984 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 30, 1984
- Review
- 82 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK833892 Coatest Factor ViiiKabivitrum, Inc. · 1984
- Descendant · cites it directly · 2 of its ownK042576 Coatest SP FviiiInstrumentation Laboratory CO · 2004
- Descendant · 2 generations on · 1 of its ownK193204 Cryocheck Chromogenic Factor VIIIPrecision Biologic · 2020
- Descendant · cites it directly · 1 of its ownK981038 Coamatic Factor ViiiInstrumentation Laboratory CO · 1998
- Descendant · 3 generations on · 0 of its ownK251440 CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK052825 Visulize Factor Viii Antigen Kit, Model Fviii-AGAffinity Biologicals, Inc. · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042576Coatest SP FviiiInstrumentation Laboratory CO · 2004 · cites it directly2descendants
- K193204Cryocheck Chromogenic Factor VIIIPrecision Biologic · 2020 · 2 generations on1descendant
- K981038Coamatic Factor ViiiInstrumentation Laboratory CO · 1998 · cites it directly1descendant
- K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc. · 2025 · 3 generations on0descendants
- K052825Visulize Factor Viii Antigen Kit, Model Fviii-AGAffinity Biologicals, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K833892 | Coatest Factor Viii | Kabivitrum, Inc. | 1984 | — |
| +1 | K042576 | Coatest SP Fviii | Instrumentation Laboratory CO | 2004 | — |
| +2 | K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | 2020 | — |
| +1 | K981038 | Coamatic Factor Viii | Instrumentation Laboratory CO | 1998 | — |
| +3 | K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | 2025 | — |
| +2 | K052825 | Visulize Factor Viii Antigen Kit, Model Fviii-AG | Affinity Biologicals, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 GGP? 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 GGP device
- #1 K251440 CRYOcheck Chromogenic Factor VIIIscore 10.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K042576 (Instrumentation Laboratory CO, 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GGP devicesGGP Test, Qualitative And Quantitative Factor Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GGP
153in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGP
3in 2025
MAUDE reports naming product code GGP, 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 | 153 | 2 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K833892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K833892: Coatest Factor Viii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K833892
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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