510(k) Report

FDA applicant

Zan Messgerate GmbH

Louisville, CO2 decisions2005–20060 recalls

FDA records 2 decisions for Zan Messgerate GmbH (Louisville, CO) from 2005 to 2006: 2 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BZC (Calculator, Pulmonary Function Data). Its devices cite 3 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, anesthesiology panel, where it files most

How often FDA has decided Zan Messgerate GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zan Messgerate GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zan Messgerate GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zan Messgerate GmbH’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?

  • BZGSpirometer, Diagnostic1decision
  • BZCCalculator, Pulmonary Function Data1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K052328Zan Lung-Function LabZan Messgerate GmbH · 20052cite it

What has FDA decided for it lately?

  • K052176Flowhandy ZAN100 UsbZan Messgerate GmbH · 2006
  • K052328Zan Lung-Function LabZan Messgerate GmbH · 2005

All 2 as Zan Messgerate GmbH →