# K251032: MiniMed 780G insulin pump

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed, Inc.
- Decided: Jul 1, 2025 after 89 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010362 (2001). 23 ancestors in all.
4 later devices descend from it; 3 cite it directly.
3 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232380: t:slim X2 Insulin Pump with Interoperable Technology, Tandem Diabetes Care, Inc. (2023) Summary page 5.
- K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android)), Medtronic Minimed (2024) Summary page 5.

## Most influential descendants
- K253701: SmartGuard Technology; Predictive Low Glucose Technology (2026), 1 descendant of its own
- K261962: SmartGuard Technology; Predictive Low Glucose Technology (2026), 0 descendants of its own
- K253743: MiniMed Flex pump (2026), 0 descendants of its own
- K253470: MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (2026), 0 descendants of its own

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2980-2026: Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, poten
- Jul 13, 2026 · Class II · Z-2982-2026: Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, poten
- May 27, 2026 · Class II · Z-2698-2026: A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back:
- Feb 13, 2026 · Class II · Z-1741-2026: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered 
- Jan 30, 2026 · Class II · Z-1635-2026: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk 
- Nov 2, 2025 · Class II · Z-1238-2026: A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.

## Indications for use
The MiniMed 780G insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The MiniMed 780G insulin pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The MiniMed 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data. The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older. The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K251032
Methodology: https://510kreport.com/methodology