Cleared Traditional

MiniMed 780G insulin pump

K251032 · Medtronic Minimed, Inc. · Chemistry

Jul 2025

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K251032 is an FDA 510(k) clearance for the MiniMed 780G insulin pump, a Alternate Controller Enabled Insulin Infusion Pump (Class II — Special Controls, product code QFG), submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on July 1, 2025, 89 days after receiving the submission on April 3, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5730.

Submission Details

510(k) Number	K251032 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2025
Decision Date	July 01, 2025
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QFG — Alternate Controller Enabled Insulin Infusion Pump
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5730
Definition	An Alternate Controller Enabled Insulin Infusion Pump (ace Insulin Pump) Is A Device Intended For The Infusion Of Insulin Into A Patient. The Ace Insulin Pump May Include Basal And Bolus Drug Delivery At Set Or Variable Rates. Ace Insulin Pumps Are Designed To Reliably And Securely Communicate With External Devices, Such As Automated Insulin Dosing Systems, To Allow Insulin Delivery Commands To Be Received, Executed, And Confirmed. Ace Insulin Pumps Are Intended To Be Used Both Alone And In Conjunction With Digitally Connected Medical Devices For The Purpose Of Insulin Delivery.