MiniMed 780G insulin pump
FDA 510(k) K251032 · Medtronic Minimed, Inc.
510(k) numberK251032
Submission
- Device name
- MiniMed 780G insulin pump
- Applicant
- Medtronic Minimed, Inc.
Northridge, CA, US - Received
- April 3, 2025
- Decision date
- July 1, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFG – Alternate Controller Enabled Insulin Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5730
- Specialty
- Clinical Chemistry
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…
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| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFG · Traditional | Medtronic Minimed, Inc. | 01/15/2026SE |
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| K252770 | iLet ACE PumpQFG · Special | Beta Bionics, Inc. | 09/29/2025SE |
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| K250930 | twiist systemQFG · Special | Deka Research & Development Corp. | 04/02/2025SE |
| K234027 | embecta Insulin Delivery SystemQFG · Traditional | Embecta Medical I, LLC | 08/30/2024SE |
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| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFG · Traditional | 01/15/2026SE |
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Questions and answers
When was MiniMed 780G insulin pump cleared by the FDA?
MiniMed 780G insulin pump (K251032) received a 510(k) decision of Substantially Equivalent on July 1, 2025, 89 days after the submission was received.
What is the product code of K251032?
The FDA product code is QFG – Alternate Controller Enabled Insulin Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 880.5730.