510(k) Report

FDA applicant

Par Medizintechnik GmbH & Co. KG

Berlin, DE2 decisions2001–20170 recalls

FDA records 2 decisions for Par Medizintechnik GmbH & Co. KG (Berlin, DE) from 2001 to 2017: 2 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Par Medizintechnik GmbH”.

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 Par Medizintechnik GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Par Medizintechnik GmbH & Co. KG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Par Medizintechnik GmbH & Co. KG’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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K012647Tonoport VPar Medizintechnik GmbH · 20012cite it

What has FDA decided for it lately?

  • K170966Tonoport VIPar Medizintechnik GmbH & Co. KG · 2017
  • K012647Tonoport VPar Medizintechnik GmbH · 2001

The one decision as Par Medizintechnik GmbH & Co. KG →The one decision as Par Medizintechnik GmbH →