510(k) Report

FDA applicant

Getemed Medizin- Und Informationstechnik AG

Great Neck, NY8 decisions2005–20170 recalls

FDA records 8 decisions for Getemed Medizin- Und Informationstechnik AG (Great Neck, NY) from 2005 to 2017: 8 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and MWJ (Electrocardiograph, Ambulatory (Without…). Its devices cite 13 predicates, 5 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 Getemed Medizin- Und Informationstechnik AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 22013: 32017: 1
2007high 3 (2013) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Getemed Medizin- Und Informationstechnik AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Getemed Medizin- Und…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable4decisions
  • MWJElectrocardiograph, Ambulatory (Without Analysis)4decisions

Whose devices does it build on?

Its devices cite 13 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 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.

  • K063042Cardiomem CM 3000-12BTGetemed Medizin- Und Informationstechnik AG · 20072cite it
  • K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG · 20171cites it
  • K051471CardiodayGetemed Medizin- Und Informationstechnik AG · 20051cites it
  • K130516CardiodayGetemed Medizin- Und Informationstechnik AG · 20131cites it
  • K070280Cardioday, Version 2.0Getemed Medizin- Und Informationstechnik AG · 20071cites it

What has FDA decided for it lately?

  • K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG · 2017
  • K130516CardiodayGetemed Medizin- Und Informationstechnik AG · 2013
  • K130785SEER 1000Getemed Medizin- Und Informationstechnik AG · 2013
  • K122272CardiomemGetemed Medizin- Und Informationstechnik AG · 2013
  • K063042Cardiomem CM 3000-12BTGetemed Medizin- Und Informationstechnik AG · 2007
  • K070280Cardioday, Version 2.0Getemed Medizin- Und Informationstechnik AG · 2007
  • K051686Cardiomem CM 3000-12Getemed Medizin- Und Informationstechnik AG · 2005
  • K051471CardiodayGetemed Medizin- Und Informationstechnik AG · 2005

All 8 as Getemed Medizin- Und Informationstechnik AG →