510(k) · Cleared
ClearedAdvanced D-Dimer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Jan 28, 2000 as substantially equivalent to K862156 (American Bioproducts Co., 1986) after a 148-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Jan 28, 2000
- Review
- 148 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862156 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- This deviceK992957 Advanced D-DimerDade Behring, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK081732 Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics · 2008
- Descendant · cites it directly · 0 of its ownK041438 Advanced D-Dimer AssayDade Behring, Inc. · 2004 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| 0 (this device) | K992957 | Advanced D-Dimer | Dade Behring, Inc. | 2000 | — |
| +1 | K081732 | Innovance D-Dimer and Innovance D-Dimer Controls | Siemens Healthcare Diagnostics | 2008 | — |
| +1 | K041438 | Advanced D-Dimer Assay | Dade Behring, Inc. | 2004 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 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 DAP? 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 DAP device
- #1 K253985 INNOVANCE® D-Dimer 2.0 (SMN 10873803)score 13.0 · 5 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 |
|---|---|---|---|
| * | K862156 | Asserachrom D-DI KitSummary page 1…302-631-6276 December 3, 1999 Fibrinogen/fibrin degradation products assay Class Il (864.7320) 3. Identification of the Legally Marketed Device: Asserachrom® D-Di (K862156) 4. Device Description: Polystyrene particles covalently linked to a monoclonal antibody (DDS) to the cross- linkage region of… | 1986 |
What descends from it? (2)
2 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?
How does its category compare?
All DAP devicesDAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DAP
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DAP
127in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DAP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DAP
2in 2025
MAUDE reports naming product code DAP, 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 | 2 | — | 0 | 4 |
| 2008 | 3 | 127 | 0 | 10 |
| 2009 | 1 | — | 0 | 13 |
| 2010 | 2 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 1 | — | 1 | 38 |
| 2016 | 2 | — | 0 | 20 |
| 2017 | 1 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 7 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma, and aids in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).
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/K992957 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992957: Advanced D-Dimer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992957
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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