510(k) · Cleared
ClearedK-Assay Fibrinogen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kamiya Biomedical Co. · GIS Test, Fibrinogen
Cleared on Dec 6, 1999 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 6, 1999
- Review
- 53 days
- Class
- Class II
- Product code
- GIS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993482 K-Assay FibrinogenKamiya Biomedical Co. · 1999
- Descendant · cites it directly · 0 of its ownK143470 Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme…Diazyme Laboratories · 2016
Most influential descendants
Showing 1 of 1 · See all- K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control…Diazyme Laboratories · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993482 | K-Assay Fibrinogen | Kamiya Biomedical Co. | 1999 | — |
| +1 | K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme… | Diazyme Laboratories | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GIS? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control… | 2016 | 0 |
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, K143470 (Diazyme Laboratories, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GIS devicesGIS Test, Fibrinogen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GIS
Too few GIS 510(k)s in any year since 2007 to give a median.
Recalls per year · GIS
No recall names GIS since 2007.
Adverse event reports per year · GIS
8in 2007
MAUDE reports naming product code GIS, 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 | 8 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 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 | — | 0 | — |
What is it indicated for?
The K-ASSAY Fibrinogen Assay is intended to be used to determine the fibrinogen levels in
disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary
fibrinolysis (the dissolution of fibrinogen in a blood clot.) FOR IN VITRO DIAGNOSTIC USE.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993482 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993482: K-Assay Fibrinogen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993482
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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