510(k) · Cleared
ClearedMammaPrint FFPE NGS Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agendia, Inc. · NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Cleared on Sep 8, 2022 as substantially equivalent to K201902 (Agendia, Inc., 2020) after a 526-day review. Its family tree reaches back 7 generations to 2007.
- Decided
- Sep 8, 2022
- Review
- 526 days
- Class
- Class II
- Product code
- NYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN070009 (2007). No later device cites it as a predicate yet.
- Root · 7 generations backDEN070009 MammaprintAgendia BV · 2007
- 6 generations backK070675 MammaprintAgendia BV · 2007 · Recalled
- 5 generations backK080252 Modification to MammaprintAgendia BV · 2008 · Recalled
- 4 generations backK081092 Modification to MammaprintAgendia · 2009 · Recalled
- 3 generations backK101454 MammaprintAgendia · 2011
- 2 generations backK141142 Mammaprint FfpeAgendia · 2015
- 1 generation backK201902 MammaPrintAgendia, Inc. · 2020
- This deviceK210973 MammaPrint FFPE NGS KitAgendia, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN070009 | Mammaprint | Agendia BV | 2007 | — |
| −6 | K070675 | Mammaprint | Agendia BV | 2007 | 1 |
| −5 | K080252 | Modification to Mammaprint | Agendia BV | 2008 | 1 |
| −4 | K081092 | Modification to Mammaprint | Agendia | 2009 | 1 |
| −3 | K101454 | Mammaprint | Agendia | 2011 | — |
| −2 | K141142 | Mammaprint Ffpe | Agendia | 2015 | — |
| −1 | K201902 | MammaPrint | Agendia, Inc. | 2020 | — |
| 0 (this device) | K210973 | MammaPrint FFPE NGS Kit | Agendia, Inc. | 2022 | — |
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 K201902 MammaPrintscore 4.8 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K201902 | MammaPrintSummary page 4…t, RNA gene expression, breast cancer Classification Name Gene expression profiling test system for breast cancer prognosis Primary Predicate Device MammaPrint FFPE (K201902) Reference Predicate Device MammaPrint FFPE (K141142)… | 2020 |
| † | K141142 | Mammaprint Ffpe | 2015 |
| † | K101454 | Mammaprint | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
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. 2022, 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?
The MammaPrint FFPE NGS kit is a qualitative in vitro diagnostic test for use by clinical laboratories using target enrichment Next Generation Sequencing (NGS) technology for gene expression profiling of the 70-gene MammaPrint Breast Cancer signature on formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue samples. The test is used to assess a patient’s risk to develop distant metastasis within 5 years and up to 10 years after diagnosis. The…
Read the full statement (114 words)
The MammaPrint FFPE NGS kit is a qualitative in vitro diagnostic test for use by clinical laboratories using target
enrichment Next Generation Sequencing (NGS) technology for gene expression profiling of the 70-gene MammaPrint
Breast Cancer signature on formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue samples. The test is used to
assess a patient’s risk to develop distant metastasis within 5 years and up to 10 years after diagnosis.
The MammaPrint FFPE NGS kit is performed for breast cancer patients with Stage I or Stage 1l disease, with tumor size <
5.0 cm and lymph node negative. The test result is indicated for use by physicians as a prognostic marker only, along with
other clinicopathological factors.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210973: MammaPrint FFPE NGS Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210973
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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