# NYI: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

- Device class: 2; regulation: 21 CFR 866.6040; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 526 days (middle half 526–526)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2007: 2
- 2008: 1
- 2009: 1
- 2011: 1
- 2013: 1
- 2014: 1
- 2015: 1
- 2020: 1
- 2022: 1

## Most-cited predicates
- DEN070009: Mammaprint (2007), cited by 4
- K081092: Modification to Mammaprint (2009), cited by 2
- K080252: Modification to Mammaprint (2008), cited by 1
- K201902: MammaPrint (2020), cited by 1
- K141142: Mammaprint Ffpe (2015), cited by 1
- K130010: Prosigna (TM) Breast Cancer Prognostic Gene Signature Assay (2013), cited by 1
- K070675: Mammaprint (2007), cited by 1
- K101454: Mammaprint (2011), cited by 1

Source page: https://510kreport.com/product-code/NYI
Data by year (CSV): https://510kreport.com/product-code/NYI.csv