510(k) · Cleared
Recalled · 2010Modification to Mammaprint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agendia · NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Cleared on Dec 11, 2009 as substantially equivalent to K080252 (Agendia BV, 2008) after a 603-day review. Its family tree reaches back 3 generations to 2007. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 11, 2009
- Review
- 603 days
- Class
- Class II
- Product code
- NYI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN070009 (2007). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN070009 MammaprintAgendia BV · 2007
- 2 generations backK070675 MammaprintAgendia BV · 2007 · Recalled
- 1 generation backK080252 Modification to MammaprintAgendia BV · 2008 · Recalled
- This deviceK081092 Modification to MammaprintAgendia · 2009
- Descendant · cites it directly · 3 of its ownK101454 MammaprintAgendia · 2011
- Descendant · 2 generations on · 2 of its ownK141142 Mammaprint FfpeAgendia · 2015
- Descendant · 3 generations on · 1 of its ownK201902 MammaPrintAgendia, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK130010 Prosigna (TM) Breast Cancer Prognostic Gene Signature AssayNanostring Technologies · 2013
- Descendant · 4 generations on · 0 of its ownK210973 MammaPrint FFPE NGS KitAgendia, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101454MammaprintAgendia · 2011 · cites it directly3descendants
- K141142Mammaprint FfpeAgendia · 2015 · 2 generations on2descendants
- K201902MammaPrintAgendia, Inc. · 2020 · 3 generations on1descendant
- K130010Prosigna (TM) Breast Cancer Prognostic Gene Signature AssayNanostring Technologies · 2013 · cites it directly1descendant
- K210973MammaPrint FFPE NGS KitAgendia, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN070009 | Mammaprint | Agendia BV | 2007 | — |
| −2 | K070675 | Mammaprint | Agendia BV | 2007 | 1 |
| −1 | K080252 | Modification to Mammaprint | Agendia BV | 2008 | 1 |
| 0 (this device) | K081092 | Modification to Mammaprint | Agendia | 2009 | — |
| +1 | K101454 | Mammaprint | Agendia | 2011 | — |
| +2 | K141142 | Mammaprint Ffpe | Agendia | 2015 | — |
| +3 | K201902 | MammaPrint | Agendia, Inc. | 2020 | — |
| +1 | K130010 | Prosigna (TM) Breast Cancer Prognostic Gene Signature Assay | Nanostring Technologies | 2013 | — |
| +4 | K210973 | MammaPrint FFPE NGS Kit | Agendia, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 NYI? 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 NYI device
- #1 K210973 MammaPrint FFPE NGS Kitscore 5.8 · 7 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K080252 | Modification to Mammaprint Cleared while this submission was under review Summary page 1…Multivariate device for cancer prognosis 8. Classification Class 11,regulated under 21 CFR 866.6040, product code NYI 9. Predicate Device Agendia By's MammaPrint (k<080252) .10. Device Description The MammaPrint service i's a microarray based gene expression analysis of a tumor. The a… | 2008 |
| † | K070675 | Mammaprint | 2007 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2010 | Not classified | Z-1321-2010 | Other | Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk. This over reporting of risk did not cause direct injury to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K101454 (Agendia, 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NYI devicesNYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NYI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NYI
Too few NYI 510(k)s in any year since 2007 to give a median.
Recalls per year · NYI
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NYI
1in 2023
MAUDE reports naming product code NYI, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MammaPrint® is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of fresh breast cancer tissue samples to assess a patients' risk for distant metastasis (up to 10 years for patients less than 61 years old, up to 5 years for patients ≥ 61 years).
The test is performed for breast cancer patients with Stage I or Stage II disease, with a tumor size of ≤ 5.0 cm and lymph node negative. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081092 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081092: Modification to Mammaprint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081092
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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