510(k) · Cleared
ClearedMammaprint Ffpe
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 Jan 23, 2015 as substantially equivalent to K101454 (Agendia, 2011) after a 266-day review. Its family tree reaches back 5 generations to 2007. 2 later devices descend from it.
- Decided
- Jan 23, 2015
- Review
- 266 days
- Class
- Class II
- Product code
- NYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070009 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backDEN070009 MammaprintAgendia BV · 2007
- 4 generations backK070675 MammaprintAgendia BV · 2007 · Recalled
- 3 generations backK080252 Modification to MammaprintAgendia BV · 2008 · Recalled
- 2 generations backK081092 Modification to MammaprintAgendia · 2009 · Recalled
- 1 generation backK101454 MammaprintAgendia · 2011
- This deviceK141142 Mammaprint FfpeAgendia · 2015
- Descendant · cites it directly · 1 of its ownK201902 MammaPrintAgendia, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK210973 MammaPrint FFPE NGS KitAgendia, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070009 | Mammaprint | Agendia BV | 2007 | — |
| −4 | K070675 | Mammaprint | Agendia BV | 2007 | 1 |
| −3 | K080252 | Modification to Mammaprint | Agendia BV | 2008 | 1 |
| −2 | K081092 | Modification to Mammaprint | Agendia | 2009 | 1 |
| −1 | K101454 | Mammaprint | Agendia | 2011 | — |
| 0 (this device) | K141142 | Mammaprint Ffpe | Agendia | 2015 | — |
| +1 | K201902 | MammaPrint | Agendia, Inc. | 2020 | — |
| +2 | K210973 | MammaPrint FFPE NGS Kit | Agendia, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K101454 | MammaprintSummary page 4…ession profiling test system, for breast cancer prognosis (21 CFR 866.6040) Regulatory Class: Class II Product Code: NYI III. Predicate Device Agendia NV’s MammaPrint (k101454) IV. Device Description The MammaPrint® FFPE test is a microarray based gene expression analysis of a tumor. The analysis is b… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201902 | MammaPrint | 2020 | 1 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K201902 (Agendia, Inc., 2020) has gone furthest, with 1 descendant 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. 2015, 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® FFPE is a qualitative in vitro diagnostic test, performed in a central laboratory, using the gene expression profile obtained from formalin-fixed paraffin embedded (FFPE) breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years.
The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. The MammaPrint® FFPE result is indicated for use by physicians as a prognostic marker only, along with other clinico-pathological factors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141142: Mammaprint Ffpe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141142
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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