ClearanceBrief
510(k) K251341 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

VITAL Tubing Sets for Hemodialysis

ApplicantVital Healthcare Sdn. Bhd., Kapar, MY
DecisionSubstantially Equivalent, Jan 16, 2026
ReceivedApr 30, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251341

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.