ClearanceBrief
510(k) K251851 ยท FIP Subsystem, Water Purification

DIASAFEplusUS (F00013010)

ApplicantFresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US
DecisionSubstantially Equivalent, Oct 9, 2025
ReceivedJun 16, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251851

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.