510(k) · Cleared
ClearedMda D-Dimer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · GHH Fibrin Split Products
Cleared on Aug 7, 2002 as substantially equivalent to K000492 (Organon Teknika Corp., 2000) after a 61-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 7, 2002
- Review
- 61 days
- Class
- Class II
- Product code
- GHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000492 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000492 Mda D-DimerOrganon Teknika Corp. · 2000
- This deviceK021877 Mda D-DimerbioMerieux, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000492 | Mda D-Dimer | Organon Teknika Corp. | 2000 | — |
| 0 (this device) | K021877 | Mda D-Dimer | bioMerieux, Inc. | 2002 | — |
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 GHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K000492 | Mda D-DimerSummary page 1…tification ofthe 1e~olI-ymarketed device to which the submitter claims suhstantinl - equivalenE Device Equivalent to: 1. MDA@D-Dimer (K000492) (a) ( 4 ) A description o f the device(S1- bioMCrieus Inc. MDA@ D-Dimer is a homogeneous latex pa… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All GHH devicesGHH Fibrin Split Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GHH
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · GHH
Too few GHH 510(k)s in any year since 2007 to give a median.
Recalls per year · GHH
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GHH
3in 2025
MAUDE reports naming product code GHH, 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 | — | 1 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 1 | 12 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 2 | 8 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MDA D-Dimer is a homogeneous latex particle based immunoassay for the quantitative determination of cross-linked fibrin degradation products containing the D-dimer domain in citrated human plasma. MDA D-Dimer is an assay for use in conjunction with a clinical Pre-test Probability Assessment (PTP) model in excluding deep vein thrombosis (DVT) in outpatients suspected of a first episode of DVT. MDA D-Dimer can also be used as an aid in the assessment and evaluation of patients suspected of pulmonary embolism (PE). The assay is designed for use on the MDA automated coagulation analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021877: Mda D-Dimer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021877
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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