MiniMed 780G insulin pump— 510(k) K251032
Substantially EquivalentMedtronic Minimed, Inc.
FDA 510(k) clearance K251032 for MiniMed 780G insulin pump, Substantially Equivalent on 2025-07-01. Applicant: Medtronic Minimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Minimed, Inc.
- Product code
- Code QFG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5730
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
Recent devices under product code QFG
view allMore clearances from Medtronic Minimed, Inc.
view all- K253585 — SmartGuard technology; Predictive Low Glucose technology
- K251217 — SmartGuard technology; Predictive Low Glucose technology
- K210714 — Extended Reservoir
- K151236 — MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
- K070438 — MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
Adverse events under product code QFG
product code QFG- Death
- 228
- Injury
- 118,915
- Malfunction
- 1,001,752
- Other
- 7
- Total
- 1,120,902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K251032
K-number listed on FDA's recall record- Z-2980-2026 — MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
- Z-2982-2026 — MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
- Z-2698-2026 — MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
- Z-1741-2026 — MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
- Z-1635-2026 — MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
- Z-1238-2026 — MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K251032.
Data sourced from openFDA. This site is unofficial and independent of the FDA.