510(k) Report

FDA applicant

Cnsystems Medizintechnik GmbH

Graz, AT3 decisions2002–20231 recall

FDA records 3 decisions for Cnsystems Medizintechnik GmbH (Graz, AT) from 2002 to 2023: 3 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DSB (Plethysmograph, Impedance). Its devices cite 7 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 Cnsystems Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 12023: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cnsystems Medizintechnik GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • DSBPlethysmograph, Impedance1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K014063Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 20024cite it
  • K183521CNAP MonitorCnsystems Medizintechnik GmbH · 20191cites it

What has FDA decided for it lately?

  • K223332Task Force CORECnsystems Medizintechnik GmbH · 2023
  • K183521CNAP MonitorCnsystems Medizintechnik GmbH · 2019
  • K014063Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 20021 recall

All 3 as Cnsystems Medizintechnik GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K014063CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and…Dec 1, 2015Class II