510(k) Report

FDA applicant

Ndd Medizintechnik AG

Zurich, CH4 decisions2017–20232 recalls

FDA records 4 decisions for Ndd Medizintechnik AG (Zurich, CH) from 2017 to 2023: 4 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 5 predicates, 1 of them its own earlier devices. 2 recalls are 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 Ndd Medizintechnik AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 22022: 12023: 1
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Ndd Medizintechnik AG by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZGSpirometer, Diagnostic2decisions
  • CAHFilter, Bacterial, Breathing-Circuit1decision
  • BTYCalculator, Predicted Values, Pulmonary Function1decision

Whose devices does it build on?

Its devices cite 5 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.

  • K161536EasyOne Air SpirometerNdd Medizintechnik AG · 20171cites it
  • K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG · 20171cites it

What has FDA decided for it lately?

  • K230178EasyOne Sky SpirometerNdd Medizintechnik AG · 2023
  • K221250EasyOne FilterNdd Medizintechnik AG · 2022
  • K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG · 20172 recalls
  • K161536EasyOne Air SpirometerNdd Medizintechnik AG · 2017

All 4 as Ndd Medizintechnik AG →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K161534EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1Aug 15, 2017Class II
  • K161534EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model…Aug 15, 2017Class II