FDA applicant

Draeger Medical AG & Co. Kgaa

Telford, PA1 decision2006–20060 recalls

FDA records 1 decision for Draeger Medical AG & Co. Kgaa (Telford, PA) in 2006: 1 510(k) clearance. All are in product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). 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 Draeger Medical AG & Co. Kgaa’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Draeger Medical AG & Co. Kgaa’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Draeger”

FDA records each applicant name separately; these may or may not be the same firm.

Draeger Medical, Inc. 94 Draeger Medical Systems, Inc. 49 Draeger Medical Infant Care, Inc. 2 Draeger Medical Sytems, Inc. 2

Draeger Medical AG & Co. Kgaa

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Draeger”