510(k) Report

FDA applicant

Draeget Medical AG & Co. Kgaa

Telford, PA2 decisions2004–20040 recalls

FDA records 2 decisions for Draeget Medical AG & Co. Kgaa (Telford, PA) in 2004: 2 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 6 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 Draeget Medical AG & Co. Kgaa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Draeget Medical AG & Co. Kgaa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Draeget Medical AG & Co. Kgaa by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • CBKVentilator, Continuous, Facility Use1decision

Whose devices does it build on?

Its devices cite 6 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.

  • K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 20042cite it
  • K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa · 20041cites it

What has FDA decided for it lately?

  • K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
  • K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa · 2004

All 2 as Draeget Medical AG & Co. Kgaa →