510(k) Report

FDA applicant

Medotech A/S

Westminster, CO2 decisions2010–20120 recalls

FDA records 2 decisions for Medotech A/S (Westminster, CO) from 2010 to 2012: 2 510(k) clearances. Most are in product codes KZM (Device, Muscle Monitoring) and HCC (Device, Biofeedback). Its devices cite 5 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

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Medotech A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Medotech A/S by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medotech 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?

  • KZMDevice, Muscle Monitoring1decision
  • HCCDevice, Biofeedback1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K092675GrindcareMedotech A/S · 20102cite it

What has FDA decided for it lately?

  • K113677Grindcare MeasureMedotech A/S · 2012
  • K092675GrindcareMedotech A/S · 2010

All 2 as Medotech A/S →