510(k) Report

FDA applicant

Mobilemedtek

Louisville, KY1 decision2017–20172 recalls

FDA records 1 decision for Mobilemedtek (Louisville, KY) in 2017: 1 510(k) clearance. All are in product code GWQ (Full-Montage Standard Electroencephalograph). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2
2017high 2 (2019) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Mobilemedtek by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GWQFull-Montage Standard Electroencephalograph1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K170441ElectroTekMobilemedtek · 20171cites it

What has FDA decided for it lately?

  • K170441ElectroTekMobilemedtek · 20172 recalls

The one decision as Mobilemedtek →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K170441ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The…Oct 11, 2019Class II
  • K170441ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The…Oct 11, 2019Class II