FDA applicant
Draegerwerk AG & CO Kgaa
FDA records 8 decisions for Draegerwerk AG & CO Kgaa (Luebeck, DE) from 2010 to 2026: 8 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BZE (Heater, Breathing System W/Wo Controller (Not…). Since 2016 its 510(k)s took a median of 302 days from receipt to decision, against 309 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 of them its own earlier devices. 6 recalls are linked to its devices, 4 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Draegerwerk AG & CO Kgaa’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
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