510(k) K261530

iiSure Infusion Set by Deka Research and Development — Product Code FPA

K261530 is an FDA 510(k) premarket notification submitted by Deka Research and Development for the device "iiSure Infusion Set". The FDA issued a decision of Substantially Equivalent on June 3, 2026. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Deka Research and Development has at least 10 other 510(k) clearances on record.