510(k) Report

FDA applicant

Motilitycount Aps

Valby, DK2 decisions2019–20250 recalls

FDA records 2 decisions for Motilitycount Aps (Valby, DK) from 2019 to 2025: 2 510(k) clearances. Most are in product codes MQK (Labware, Assisted Reproduction) and POV (Semen Analysis Device). Its devices cite 2 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 Motilitycount Aps’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12025: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Motilitycount Aps by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQKLabware, Assisted Reproduction1decision
  • POVSemen Analysis Device1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps · 2025
  • K183602SwimCount Sperm Quality TestMotilitycount Aps · 2019

All 2 as Motilitycount Aps →