510(k) Report

FDA applicant

Agendia BV

Amsterdam, NL8 decisions2007–20221 recall

FDA records 8 decisions for Agendia BV (Amsterdam, NL) from 2007 to 2022: 7 510(k) clearances and 1 De Novo grant. All are in product code NYI (Classifier, Prognostic, Recurrence Risk…). Its devices cite 7 predicates, 7 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Agendia”, “Agendia, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Agendia BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 22008: 12009: 12011: 12015: 12020: 12022: 1
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Agendia BV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Agendia BV’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NYIClassifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer8decisions

Who builds on its devices?

Later devices cite its devices 11 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN070009MammaprintAgendia BV · 20074cite it
  • K081092Modification to MammaprintAgendia · 20092cite it
  • K080252Modification to MammaprintAgendia BV · 20081cites it
  • K201902MammaPrintAgendia, Inc. · 20201cites it
  • K141142Mammaprint FfpeAgendia · 20151cites it
  • K070675MammaprintAgendia BV · 20071cites it

What has FDA decided for it lately?

  • K210973MammaPrint FFPE NGS KitAgendia, Inc. · 2022
  • K201902MammaPrintAgendia, Inc. · 2020
  • K141142Mammaprint FfpeAgendia · 2015
  • K101454MammaprintAgendia · 2011
  • K081092Modification to MammaprintAgendia · 20091 recall
  • K080252Modification to MammaprintAgendia BV · 20081 recall
  • K070675MammaprintAgendia BV · 20071 recall
  • DEN070009MammaprintAgendia BV · 2007

All 3 as Agendia BV →All 3 as Agendia →All 2 as Agendia, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K070675Agendia MammaPrint, Catalog Numbers MP01, MP US version 03Mar 3, 2010