510(k) · Cleared
ClearedInnovance D-Dimer, Model OPBP09
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Nov 29, 2010 as substantially equivalent to K040882 (bioMerieux, Inc., 2004) after a 370-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it.
- Decided
- Nov 29, 2010
- Review
- 370 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862156 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 3 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 2 generations backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- 1 generation backK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- This deviceK093626 Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics · 2010
- Descendant · cites it directly · 0 of its ownK253985 INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbH · 2026
- Descendant · cites it directly · 0 of its ownK110303 Stratus CS Acute Care D-DimerSiemens Healthcare Diagnostics · 2011 · 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 |
|---|---|---|---|---|---|
| −4 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −3 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K093626 | Innovance D-Dimer, Model OPBP09 | Siemens Healthcare Diagnostics | 2010 | — |
| +1 | K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | 2026 | — |
| +1 | K110303 | Stratus CS Acute Care D-Dimer | Siemens Healthcare Diagnostics | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442Summary page 2…dical device to which equivalence is claimed and comparison information: The INNOVANCE® 0-Dimer is substantially equivalent to the VIDAS® D-Dimer ExclusionTM (k040882) assay. The INNOVANCE® D-Dimer method, like the VIDAS® 0- Dimner ExclusionTM method, is intended for use in conjunction with… | 2004 |
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253985 (Siemens Healthcare Diagnostic Products GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K040882.
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. 2010, this device’s year, is highlighted.
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?
For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Healthcare Diagnostics and Sysmex® Coagulation Systems. The INNOVANCE® D-Dimer assay is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093626 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093626: Innovance D-Dimer, Model OPBP09.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093626
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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