510(k) Report

FDA applicant

Artsmedia Denmark Aps

Virum, DK3 decisions2023–20240 recalls

FDA records 3 decisions for Artsmedia Denmark Aps (Virum, DK) from 2023 to 2024: 3 510(k) clearances. All are in product code MQL (Media, Reproductive). Since 2016 its 510(k)s took a median of 240 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Artsmedia Denmark Aps’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2023: 12024: 2
2023high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Artsmedia Denmark Aps by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQLMedia, Reproductive3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 240 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 195 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K241095ARTSMedia Semen Wash MediumArtsmedia Denmark Aps · 2024
  • K241132ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)Artsmedia Denmark Aps · 2024
  • K220715ARTSMedia In Vitro Culture Medium (AM-IVC Medium)Artsmedia Denmark Aps · 2023

All 3 as Artsmedia Denmark Aps →