510(k) Report

FDA applicant

Unisense Fertilitech A/S

Arrhus N, DK4 decisions2011–20140 recalls

FDA records 4 decisions for Unisense Fertilitech A/S (Arrhus N, DK) from 2011 to 2014: 4 510(k) clearances. All are in product code MQG (Accessory, Assisted Reproduction). Its devices cite 6 predicates, 4 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 Unisense Fertilitech A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 32014: 1
2011high 3 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Unisense Fertilitech A/S by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Unisense Fertilitech A/S’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?

  • MQGAccessory, Assisted Reproduction4decisions

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K092183Embryoscope and EmbryoslideUnisense Fertilitech A/S · 20114cite it
  • K113075Embryo Viewer SoftwareUnisense Fertilitech A/S · 20112cite it
  • K111715EmbryoscopeUnisense Fertilitech A/S · 20111cites it
  • K133712Embryoviewer SoftwareUnisense Fertilitech A/S · 20141cites it

What has FDA decided for it lately?

  • K133712Embryoviewer SoftwareUnisense Fertilitech A/S · 2014
  • K113075Embryo Viewer SoftwareUnisense Fertilitech A/S · 2011
  • K111715EmbryoscopeUnisense Fertilitech A/S · 2011
  • K092183Embryoscope and EmbryoslideUnisense Fertilitech A/S · 2011

All 4 as Unisense Fertilitech A/S →