510(k) K243841

Sparta Infusion Set for Insulin by Deka Research and Development — Product Code FPA

K243841 is an FDA 510(k) premarket notification submitted by Deka Research and Development for the device "Sparta Infusion Set for Insulin". The FDA issued a decision of Substantially Equivalent on August 1, 2025. 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.