510(k) · Cleared
ClearedHemosil D-Dimer HS 500, Controls
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 Feb 5, 2010 as substantially equivalent to K040882 (bioMerieux, Inc., 2004) and 2 other predicates after a 367-day review. Its family tree reaches back 5 generations to 1986. 1 later device descends from it.
- Decided
- Feb 5, 2010
- Review
- 367 days
- Class
- Class II
- Product code
- DAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K862156 (1986). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 4 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 3 generations backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- 2 generations backK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- 1 generation backK070927 Hemosil D-Dimer HSInstrumentation Laboratory CO · 2007
- This deviceK090264 Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO · 2010
- Descendant · cites it directly · 0 of its ownK172903 HemosIL D-Dimer HS 500Instrumentation Laboratory CO · 2017
Most influential descendants
Showing 1 of 1 · See all- K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −4 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −3 | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| −2 | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 | bioMerieux, Inc. | 2004 | — |
| −1 | K070927 | Hemosil D-Dimer HS | Instrumentation Laboratory CO | 2007 | — |
| 0 (this device) | K090264 | Hemosil D-Dimer HS 500, Controls | Instrumentation Laboratory CO | 2010 | — |
| +1 | K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (3)
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…Controls (Controls) Regulatory Class: Class HI Product Codes: DAP (Assay) and GGN (Controls) Panel: Hematology Predicate Devices: K040882 VIDAS®D D-Dimer ExclusionTm Assay K070927 HemnosiL® D-Dimer H-S K972696… | 2004 |
| * | K070927 | Hemosil D-Dimer HSSummary page 1…uct Codes: DAP (Assay) and GGN (Controls) Panel: Hematology Predicate Devices: K040882 VIDAS®D D-Dimer ExclusionTm Assay K070927 HemnosiL® D-Dimer H-S K972696 HemoslL® D-Dimer Controls Device Descriptions: HemoslIL D-… | 2007 |
| * | K972696 | IL Test D-DimerSummary page 1…Panel: Hematology Predicate Devices: K040882 VIDAS®D D-Dimer ExclusionTm Assay K070927 HemnosiL® D-Dimer H-S K972696 HemoslL® D-Dimer Controls Device Descriptions: HemoslIL D-Dimer HS 500: The D-Dimer HS 500 Latex Reagent is… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172903 | HemosIL D-Dimer HS 500 | 2017 | 0 |
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 3.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K172903 (Instrumentation Laboratory CO, 2017) 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?
HemosIL D-Dimer HS 500 is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP (RFamily Systems 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).
HemosIL D-Dimer HS 500 Controls are intended for the quality control of the D-Dimter HS 500 assay performed on the ACL TOP® Family Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090264 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090264: Hemosil D-Dimer HS 500, Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090264
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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