510(k) · Cleared
ClearedFibrinogen Calibrator Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · GFX Fibrinogen Standard
Cleared on Mar 3, 2000 as substantially equivalent to K925988 (Behring Diagnostics, Inc., 1993) after a 71-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Mar 3, 2000
- Review
- 71 days
- Class
- Class II
- Product code
- GFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925988 (1993). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K072304Fibrinogen Calibrator KitDade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925988 | Multifibren | Behring Diagnostics, Inc. | 1993 | — |
| 0 (this device) | K994341 | Fibrinogen Calibrator Kit | Dade Behring, Inc. | 2000 | — |
| +1 | K072304 | Fibrinogen Calibrator Kit | Dade Behring, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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 GFX? 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 |
|---|---|---|---|
| * | K925988 | MultifibrenSummary page 1…itro diagnostic products in commercial distribution, which are used for the establishment of reference curves. One such product is the Dade Behring Fibrinogen Standards (K925988). The Fibrinogen Calibrator Kit is substantially equivalent in intended use to the Fibrinogen Standards. The Fibrinogen Calibrato… | 1993 |
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 |
|---|---|---|---|
| K072304 | Fibrinogen Calibrator Kit | 2007 | 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?
- Its one ancestor has no recall.
- Of its descendants, K072304 (Dade Behring, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GFX devicesGFX Fibrinogen Standard: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GFX
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GFX
Too few GFX 510(k)s in any year since 2007 to give a median.
Recalls per year · GFX
No recall names GFX since 2007.
Adverse event reports per year · GFX
1in 2011
MAUDE reports naming product code GFX, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 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?
Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of
fibrinogen by the method of Clauss using Dade Behring Multifibrin U.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994341 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994341: Fibrinogen Calibrator Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994341
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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