FDA applicant
Fresenius Medical Care Renal Therapies Group, LLC
FDA records 53 decisions for Fresenius Medical Care Renal Therapies Group, LLC (Waltham, MA) from 2013 to 2026: 53 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Since 2016 its 510(k)s took a median of 189 days from receipt to decision, against 199 for FDA’s reviews in the same codes and years. Its devices cite 75 predicates, 32 of them its own earlier devices. 57 recalls are linked to its devices, 13 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fresenius Medical Care Renal Therapies Group, LLC’s devices, and how often a recall has named them.
FDA decisions per year
11in 2025
2026 so far, outlined.
Recalls per year
12in 2026
Class I Class II/III not classified
Planning a device like Fresenius Medical Care Renal Therapies…’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”
FDA records each applicant name separately; these may or may not be the same firm.