FDA applicant
Draeger Medical Systems, Inc.
FDA records 49 decisions for Draeger Medical Systems, Inc. (Danvers, MA) from 2003 to 2026: 49 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and MSX (System, Network And Communication…). Since 2016 its 510(k)s took a median of 201 days from receipt to decision, against 196 for FDA’s reviews in the same codes and years. Its devices cite 103 predicates, 46 of them its own earlier devices. 31 recalls are linked to its devices, 5 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Draeger Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Draeger Medical Systems, Inc.’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 “Draeger”
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