De Novo · Granted
GrantedMammaprint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agendia BV · NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Granted on Feb 6, 2007 as a new device type through De Novo after a 7-day review. 12 later devices descend from it.
- Decided
- Feb 6, 2007
- Review
- 7 days
- Class
- Class II
- Product code
- NYI
- Recalls
- None
12 later devices descend from it, 4 citing it directly.
- This deviceDEN070009 MammaprintAgendia BV · 2007
- Descendant · cites it directly · 8 of its ownK070675 MammaprintAgendia BV · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK080252 Modification to MammaprintAgendia BV · 2008 · Recalled
- Descendant · 3 generations on · 6 of its ownK081092 Modification to MammaprintAgendia · 2009 · Recalled
- Descendant · 4 generations on · 3 of its ownK101454 MammaprintAgendia · 2011
- Descendant · 5 generations on · 2 of its ownK141142 Mammaprint FfpeAgendia · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K070675MammaprintAgendia BV · 2007 · cites it directly8descendants
- K080252Modification to MammaprintAgendia BV · 2008 · 2 generations on7descendants
- K081092Modification to MammaprintAgendia · 2009 · 3 generations on6descendants
- K101454MammaprintAgendia · 2011 · 4 generations on3descendants
- K141142Mammaprint FfpeAgendia · 2015 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN070009 | Mammaprint | Agendia BV | 2007 | — |
| +1 | K070675 | Mammaprint | Agendia BV | 2007 | 1 |
| +2 | K080252 | Modification to Mammaprint | Agendia BV | 2008 | 1 |
| +3 | K081092 | Modification to Mammaprint | Agendia | 2009 | 1 |
| +4 | K101454 | Mammaprint | Agendia | 2011 | — |
| +5 | K141142 | Mammaprint Ffpe | Agendia | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (12)
See all 124 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?
- Of its descendants, K070675 (Agendia BV, 2007) has gone furthest, with 8 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. 2007, 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 | — |
https://510kreport.com/device/DEN070009 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN070009: Mammaprint.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN070009
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026