510(k) Report

FDA applicant

Vitasystems GmbH

Chemnitz, DE3 decisions2010–20160 recalls

FDA records 3 decisions for Vitasystems GmbH (Chemnitz, DE) from 2010 to 2016: 3 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 4 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2016

2010: 12015: 12016: 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 — Vitasystems GmbH by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone2decisions
  • DSIDetector And Alarm, Arrhythmia1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100383Vitaphone. Model 100 BTVitasystems GmbH · 20101cites it

What has FDA decided for it lately?

  • K153477EMMa Electronic Monitoring ManagementVitasystems GmbH · 2016
  • K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH · 2015
  • K100383Vitaphone. Model 100 BTVitasystems GmbH · 2010

All 3 as Vitasystems GmbH →