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 Sep 19, 2007 as substantially equivalent to K994341 (Dade Behring, Inc., 2000) after a 33-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Sep 19, 2007
- Review
- 33 days
- Class
- Class II
- Product code
- GFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925988 (1993). 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 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 |
|---|---|---|---|
| * | K994341 | Fibrinogen Calibrator KitSummary page 1…rinogen Calibrator Kit / Fibrinogen determination system, Class 11 (864.7340) 3. Identification of the Legally Marketed Device: Fibrinogen Calibrator Kit (K994341) 4. Device Description: The Fibrinogen Calibrators are lyophilized calibrators prepared using pooled huma… | 2000 |
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 14 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GFX devicesGFX Fibrinogen Standard: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Multifibren TM U.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072304 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072304: 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/K072304
Report an extraction error
Are you the manufacturer?
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