510(k) K251854

SteadiSet infusion set by Tandem Diabetes Care — Product Code FPA

K251854 is an FDA 510(k) premarket notification submitted by Tandem Diabetes Care for the device "SteadiSet infusion set". The FDA issued a decision of Substantially Equivalent on August 6, 2025. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Tandem Diabetes Care has at least 10 other 510(k) clearances on record.