510(k) Report

FDA applicant

Microlife Intellectual Property GmbH, Switzerland

Widnau, CH3 decisions2014–20150 recalls

FDA records 3 decisions for Microlife Intellectual Property GmbH, Switzerland (Widnau, CH) from 2014 to 2015: 3 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 6 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, cardiovascular panel, where it files most

How often FDA has decided Microlife Intellectual Property GmbH, Switzerland’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2014: 12015: 2
2014high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Microlife Intellectual Property GmbH, Switzerland by year, 2014–2026Sources: 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-Invasive3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 20153cite it
  • K140572Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 20142cite it
  • K151330Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 20151cites it

What has FDA decided for it lately?

  • K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015
  • K151330Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015
  • K140572Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2014

All 3 as Microlife Intellectual Property GmbH, Switzerland →

Other applicant names beginning “Microlife”

FDA records each applicant name separately; these may or may not be the same firm.

Microlife Intellectual Property GmbH 54Microlife Corp. 16Microlife Intellectual Property Gmb 1Microlife Systems AG 1