510(k) · Cleared
ClearedMammaprint
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 28, 2011 as substantially equivalent to K081092 (Agendia, 2009) after a 248-day review. Its family tree reaches back 4 generations to 2007. 3 later devices descend from it.
- Decided
- Jan 28, 2011
- Review
- 248 days
- Class
- Class II
- Product code
- NYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN070009 (2007). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN070009 MammaprintAgendia BV · 2007
- 3 generations backK070675 MammaprintAgendia BV · 2007 · Recalled
- 2 generations backK080252 Modification to MammaprintAgendia BV · 2008 · Recalled
- 1 generation backK081092 Modification to MammaprintAgendia · 2009 · Recalled
- This deviceK101454 MammaprintAgendia · 2011
- Descendant · cites it directly · 2 of its ownK141142 Mammaprint FfpeAgendia · 2015
- Descendant · 2 generations on · 1 of its ownK201902 MammaPrintAgendia, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK210973 MammaPrint FFPE NGS KitAgendia, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070009 | Mammaprint | Agendia BV | 2007 | — |
| −3 | K070675 | Mammaprint | Agendia BV | 2007 | 1 |
| −2 | K080252 | Modification to Mammaprint | Agendia BV | 2008 | 1 |
| −1 | K081092 | Modification to Mammaprint | Agendia | 2009 | 1 |
| 0 (this device) | K101454 | Mammaprint | Agendia | 2011 | — |
| +1 | K141142 | Mammaprint Ffpe | Agendia | 2015 | — |
| +2 | K201902 | MammaPrint | Agendia, Inc. | 2020 | — |
| +3 | K210973 | MammaPrint FFPE NGS Kit | Agendia, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K081092 | Modification to MammaprintSummary page 1…Name 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 (k081092) Agendia BV-Amnsterdamn 2010- 1001 Additional Scanner… | 2009 |
| † | K080252 | Modification to Mammaprint | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141142 | Mammaprint Ffpe | 2015 | 2 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K141142 (Agendia, 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K081092.
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. 2011, 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 aqualitative in vitro diagnostic test service, performed in a central 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 11disease, with a tumor size of 5 5.0 cm and lymph node negative. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with a other clinicopathological factors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101454: Mammaprint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101454
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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