Medtronic Minimed - FDA 510(k) Cleared Devices

Medtronic Minimed, is a diabetes management solutions company based in Northridge, US. The company specializes in insulin delivery and glucose monitoring technologies.

Medtronic Minimed has received 44 FDA 510(k) clearances from 49 total submissions since 1986. The company's regulatory focus centers on General Hospital devices, which represent 92% of submissions. Recent clearances in 2026 demonstrate continued active development and regulatory engagement.

The company's cleared device portfolio includes insulin infusion pumps, infusion sets, mobile applications for diabetes management, and related delivery system components. Notable products include the Paradigm insulin pump series, MiniMed Go App, InPen System App, and various infusion set models.

Explore the complete regulatory record by reviewing individual device names, product codes, and FDA 510(k) clearance dates in the database.

2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.