510(k) · Cleared
ClearedVidas D-Dimer New (DD2) Assay Model#30 442
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Oct 3, 2002 as substantially equivalent to K973819 (Biomerieux Vitek, Inc., 1998) after a 204-day review. Its family tree reaches back 2 generations to 1986. 21 later devices descend from it.
- Decided
- Oct 3, 2002
- Review
- 204 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862156 (1986). 21 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 1 generation backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- This deviceK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- Descendant · cites it directly · 19 of its ownK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- Descendant · 2 generations on · 8 of its ownK070927 Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007
- Descendant · 2 generations on · 2 of its ownK093626 Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics · 2010
- Descendant · 2 generations on · 2 of its ownK083518 Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009
- Descendant · 3 generations on · 1 of its ownK151534 HemosIL D-Dimer HSInstrumentation Laboratory CO · 2015
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K040882Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004 · cites it directly19descendants
- K070927Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007 · 2 generations on8descendants
- K093626Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics · 2010 · 2 generations on2descendants
- K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009 · 2 generations on2descendants
- K151534HemosIL D-Dimer HSInstrumentation Laboratory CO · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −1 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| 0 (this device) | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| +1 | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 | bioMerieux, Inc. | 2004 | — |
| +2 | K070927 | Hemosil D-Dimer HS | Instrumentation Laboratory CO | 2007 | — |
| +2 | K093626 | Innovance D-Dimer, Model OPBP09 | Siemens Healthcare Diagnostics | 2010 | — |
| +2 | K083518 | Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls | Instrumentation Laboratory CO | 2009 | — |
| +3 | K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K973819 | Vidas D-Dimer (DD) Assay Our reading of the summary gave K972819, FDA’s number for Vigil TDM Controls (Beckman Instruments, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VIDAS D-Dimer (DD) Assay”. | 1998 |
What descends from it? (21)
See all 212 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K040882 (bioMerieux, Inc., 2004) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K973819.
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?
The VIDAS D-Dimer New assay indicated for use as an aid in the diagnosis of deep venous thrombosis and pulmonary embolism disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020810: Vidas D-Dimer New (DD2) Assay Model#30 442.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020810
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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