510(k) Report

FDA applicant

Hellige GmbH

D7800 Freiburg Im Breisga, DE2 decisions1995–19960 recalls

FDA records 2 decisions for Hellige GmbH (D7800 Freiburg Im Breisga, DE) from 1995 to 1996: 2 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and LDD (Dc-Defibrillator, Low-Energy, (Including…). 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 Hellige GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hellige GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hellige 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?

  • DPSElectrocardiograph1decision
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)1decision

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.

  • K950989CardiosmartHellige GmbH · 19961cites it

What has FDA decided for it lately?

  • K950989CardiosmartHellige GmbH · 1996
  • K951110Cardio ServHellige GmbH · 1995

All 2 as Hellige GmbH →