FDA applicant
Fresenius Medical Care North America, Design Cente
FDA records 5 decisions for Fresenius Medical Care North America, Design Cente (Waltham, MA) from 2010 to 2013: 5 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FKX (System, Peritoneal, Automatic Delivery). Its devices cite 7 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fresenius Medical Care North America, Design Cente’s devices, and how often a recall has named them.
FDA decisions per year
2in 2013
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Fresenius Medical Care North America…’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 “Fresenius”
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