510(k) Report

FDA applicant

Biocomfort Diagnostics GmbH & Co. KG

Neuhausen A.D.F., DE2 decisions2008–20090 recalls

FDA records 2 decisions for Biocomfort Diagnostics GmbH & Co. KG (Neuhausen A.D.F., DE) from 2008 to 2009: 2 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DRG (Transmitters And Receivers, Physiological…). Its devices cite 2 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 Biocomfort Diagnostics GmbH & Co. KG’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 — Biocomfort Diagnostics GmbH & Co. KG by year, 2008–2026Sources: 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-Invasive1decision
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K081499Health Manager, Version 1.1Biocomfort Diagnostics GmbH & Co. KG · 2009
  • K081498Tenso-Comfort Blood Pressure Meter, Models BPM 105 and BPM 205Biocomfort Diagnostics GmbH & Co. KG · 2008

All 2 as Biocomfort Diagnostics GmbH & Co. KG →