510(k) K253512

MiniMed Go App by Medtronic Minimed — Product Code NDC

K253512 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "MiniMed Go App". The FDA issued a decision of Substantially Equivalent on January 8, 2026. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Medtronic Minimed has at least 10 other 510(k) clearances on record.