510(k) K253534

Pivot Insulin Delivery System by Modular Medical — Product Code LZG

K253534 is an FDA 510(k) premarket notification submitted by Modular Medical for the device "Pivot Insulin Delivery System". The FDA issued a decision of Substantially Equivalent on April 8, 2026. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Modular Medical has at least 1 other 510(k) clearance on record.