510(k) · Cleared
ClearedHemosil D-Dimer HS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Cleared on Sep 17, 2007 as substantially equivalent to K040882 (bioMerieux, Inc., 2004) after a 167-day review. Its family tree reaches back 4 generations to 1986. 8 later devices descend from it.
- Decided
- Sep 17, 2007
- Review
- 167 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862156 (1986). 8 later devices descend from it, 4 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 deviceK070927 Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007
- Descendant · cites it directly · 2 of its ownK083518 Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009
- Descendant · cites it directly · 1 of its ownK151534 HemosIL D-Dimer HSInstrumentation Laboratory CO · 2015
- Descendant · cites it directly · 1 of its ownK090264 Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO · 2010
- Descendant · 2 generations on · 0 of its ownK221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2…Instrumentation Laboratory CO · 2023
- Descendant · 2 generations on · 0 of its ownK172903 HemosIL D-Dimer HS 500Instrumentation Laboratory CO · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009 · cites it directly2descendants
- K151534HemosIL D-Dimer HSInstrumentation Laboratory CO · 2015 · cites it directly1descendant
- K090264Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO · 2010 · cites it directly1descendant
- K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023 · 2 generations on0descendants
- K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO · 2017 · 2 generations on0descendants
View 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) | K070927 | Hemosil D-Dimer HS | Instrumentation Laboratory CO | 2007 | — |
| +1 | K083518 | Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls | Instrumentation Laboratory CO | 2009 | — |
| +1 | K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2015 | — |
| +1 | K090264 | Hemosil D-Dimer HS 500, Controls | Instrumentation Laboratory CO | 2010 | — |
| +2 | K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2… | Instrumentation Laboratory CO | 2023 | — |
| +2 | K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 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 1…n, Antiserum, Control Device Class: Class II Regulation No.: 864.7320 Product Code: DAP Panel: Hematology Predicate Device: K040882 Biomerieux Vidas® D-Dimer Exclusion Assay Device Intended Use: HemoslL D-Dimer HS is an automated latex enhan… | 2004 |
What descends from it? (8)
4 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 21 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083518 (Instrumentation Laboratory CO, 2009) has gone furthest, with 2 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. 2007, 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?
HemosIL D-Dimer HS is an automated latex enhanced immunoassay for the quantitative
determination of D-Dimer in human citrated plasma on the ACL TOP for use in conjunction with
a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism
(VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism
(PE).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070927 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070927: Hemosil D-Dimer HS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070927
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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