510(k) Report

FDA applicant

Telovital GmbH Telemedizin

Alexandria, VA2 decisions2008–20090 recalls

FDA records 2 decisions for Telovital GmbH Telemedizin (Alexandria, VA) from 2008 to 2009: 2 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DXH (Transmitters And Receivers…). 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 Telovital GmbH Telemedizin’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Telovital GmbH Telemedizin by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Telovital GmbH Telemedizin’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?

  • DPSElectrocardiograph1decision
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

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.

  • K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 20081cites it

What has FDA decided for it lately?

  • K083630Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2009
  • K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008

All 2 as Telovital GmbH Telemedizin →