MiniMed 780G insulin pump
FDA 510(k) clearance K251032 · decided 2025-07-01
Clearance details
- K-number
- K251032
- Device name
- MiniMed 780G insulin pump
- Applicant
- Medtronic Minimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-03
- Decision date
- 2025-07-01
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- QFG
- Device class
- 2
- Regulation number
- 880.5730
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 recall (Z-2698-2026) | Medtronic MiniMed, Inc. | 2026-07-08 |
| MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) recall (Z-1741-2026) | Medtronic MiniMed, Inc. | 2026-04-02 |
| MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 recall (Z-1635-2026) | Medtronic MiniMed, Inc. | 2026-03-24 |
| MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 Th recall (Z-1238-2026) | Medtronic MiniMed, Inc. | 2026-02-02 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiniMed 670G System (P160017/S133) | Medtronic Minimed, Inc. | 2025-12-18 |
| MiniMed 780G System (P160017/S125) | Medtronic Minimed, Inc. | 2025-12-11 |
| MiniMed 670G system MiniMed 770G system MiniMed 780G system (P160017/S131) | Medtronic Minimed, Inc. | 2025-12-10 |
| Simplera Sync Sensor; Guardian 4 Sensor (P250012/S005) | Medtronic Minimed, Inc. | 2025-12-10 |
| MiniMed 780G System (P160017/S134) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera Sync Sensor (P250012/S007) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera Sync Sensor (P250012/S006) | Medtronic Minimed, Inc. | 2025-12-05 |
| MiniMed 780G System (P160017/S132) | Medtronic Minimed, Inc. | 2025-12-05 |