FDA applicant

Cardio Tek, BV

Ballwin, MO2 decisions2014–20161 recall

FDA records 2 decisions for Cardio Tek, BV (Ballwin, MO) from 2014 to 2016: 2 510(k) clearances. All are in product code DQK (Computer, Diagnostic, Programmable). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2016

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2017

2014high 1 (2017) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Cardio Tek, BV by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Cardio Tek, BV

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?