FDA applicant

Drager Medical AG & Co. Kgaa

Telford, PA3 decisions2005–20107 recalls

FDA records 3 decisions for Drager Medical AG & Co. Kgaa (Telford, PA) from 2005 to 2010: 3 510(k) clearances. All are in product code CBK (Ventilator, Continuous, Facility Use). Its devices cite 18 predicates, 3 of them its own earlier devices. 7 recalls are linked to its devices, 4 Class I.

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 Drager Medical AG & Co. Kgaa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Drager 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.

See the 510(k) Report

Other applicant names beginning “Drager”

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

Drager, Inc. 20 Drager Medizintechnik GmbH 8 Drager Medical B.V. 2 Drager Safety 1

Drager 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?

What has been recalled?

Other applicant names beginning “Drager”