FDA applicant
Drägerwerk AG & Co. KGaA
FDA records 7 decisions for Drägerwerk AG & Co. KGaA (Luebeck, DE) from 2019 to 2026: 7 510(k) clearances. Most are in product codes FMZ (Incubator, Neonatal) and BSZ (Gas-Machine, Anesthesia). Since 2016 its 510(k)s took a median of 167 days from receipt to decision, against 204 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 2 of them its own earlier devices. 13 recalls are linked to its devices, 12 Class I.
FDA’s records also spell it “Dragerwerk AG & CO Kgaa”, “Drägerwerk AG Co. Kgaa”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Drägerwerk 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
2in 2026
Class I Class II/III not classified
Planning a device like Drägerwerk 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) ReportOther applicant names beginning “Drägerwerk”
FDA records each applicant name separately; these may or may not be the same firm.