510(k) Report

FDA applicant

Aeon Astron Europe B.V.

Leiden, NL3 decisions2009–20180 recalls

FDA records 3 decisions for Aeon Astron Europe B.V. (Leiden, NL) from 2009 to 2018: 3 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and OLR (Oral Wound Dressing). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Aeon Astron Europe B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2009: 12012: 12018: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Aeon Astron Europe B.V. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)2decisions
  • OLROral Wound Dressing1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080868Aongen Collagen MatrixAeon Astron Europe B.V. · 20091cites it

What has FDA decided for it lately?

  • K173223ologen Collagen MatrixAeon Astron Europe B.V. · 2018
  • K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V. · 2012
  • K080868Aongen Collagen MatrixAeon Astron Europe B.V. · 2009

All 3 as Aeon Astron Europe B.V. →