ClearanceBrief
510(k) K251854 ยท FPA Set, Administration, Intravascular

SteadiSet infusion set

ApplicantTandem Diabetes Care, San Diego CA, US
DecisionSubstantially Equivalent, Aug 6, 2025
ReceivedJun 17, 2025
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K251854

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.