510(k) Report

FDA applicant

Ndd Medizitechnik AG

Andover, MA3 decisions2009–20120 recalls

FDA records 3 decisions for Ndd Medizitechnik AG (Andover, MA) from 2009 to 2012: 3 510(k) clearances. Most are in product codes BTY (Calculator, Predicted Values, Pulmonary Function) and BZG (Spirometer, Diagnostic). 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 Ndd Medizitechnik AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 12010: 12012: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Ndd Medizitechnik AG by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BTYCalculator, Predicted Values, Pulmonary Function2decisions
  • BZGSpirometer, Diagnostic1decision

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 3 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.

  • K120635Easyone Pro Respiratory Testing DeviceNdd Medizitechnik AG · 20121cites it
  • K091428Easyone Pro Respiratory Analysis SystemNdd Medizitechnik AG · 20101cites it
  • K090034Easy on-PC SpirometerNdd Medizitechnik AG · 20091cites it

What has FDA decided for it lately?

  • K120635Easyone Pro Respiratory Testing DeviceNdd Medizitechnik AG · 2012
  • K091428Easyone Pro Respiratory Analysis SystemNdd Medizitechnik AG · 2010
  • K090034Easy on-PC SpirometerNdd Medizitechnik AG · 2009

All 3 as Ndd Medizitechnik AG →