# DEN070009: Mammaprint

- Pathway: De Novo (Post-NSE)
- Applicant: Agendia BV
- Decided: Feb 6, 2007 after 7 days
- Product code: NYI (Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K070675: Mammaprint (2007), 8 descendants of its own
- K080252: Modification to Mammaprint (2008), 7 descendants of its own
- K081092: Modification to Mammaprint (2009), 6 descendants of its own
- K101454: Mammaprint (2011), 3 descendants of its own
- K141142: Mammaprint Ffpe (2015), 2 descendants of its own

Source page: https://510kreport.com/device/DEN070009
Methodology: https://510kreport.com/methodology