MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
FDA 510(k) clearance K253470 · decided 2026-01-15
Clearance details
- K-number
- K253470
- Device name
- MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
- Applicant
- Medtronic Minimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-10-10
- Decision date
- 2026-01-15
- Days to decision
- 97 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| twiist Automated Insulin Delivery (AID) System (K261672) | Deka Research and Development | 2026-06-17 |
| iLet ACE Pump (K253976) | Beta Bionics, Inc. | 2026-04-30 |
| MiniMed Flex pump (K253743) | Medtronic Minimed, Inc. | 2026-03-12 |
| Tandem Mobi insulin pump with interoperable technology (K253074) | Tandem Diabetes Care, Inc. | 2025-11-06 |
| iLet ACE Pump (K252770) | Beta Bionics, Inc. | 2025-09-29 |
| t:slim X2 insulin pump with interoperable technology (K250792) | Tandem Diabetes Care, Inc. | 2025-09-24 |
| MiniMed 780G insulin pump (K251032) | Medtronic Minimed, Inc. | 2025-07-01 |
| twiist system (K250930) | Deka Research & Development Corp. | 2025-04-02 |
| embecta Insulin Delivery System (K234027) | Embecta Medical I, LLC | 2024-08-30 |
| Tandem Mobi Insulin Pump with interoperable technology (K241078) | Tandem Diabetes Care, Inc. | 2024-07-26 |
| DEKA ACE Pump System (K241178) | Deka Research and Development | 2024-05-24 |
| Tandem Mobi insulin pump with interoperable technology (K240309) | Tandem Diabetes Care, Inc. | 2024-03-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump (P160017/S139) | Medtronic Minimed, Inc. | 2026-08-05 |
| Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S (P160017/S138) | Medtronic Minimed, Inc. | 2026-07-21 |
| Simplera Sync (P250012/S011) | Medtronic Minimed, Inc. | 2026-07-21 |
| MiniMed 780G System (P160017/S135) | Medtronic Minimed, Inc. | 2026-06-12 |
| Simplera Sync Sensor (P250012/S008) | Medtronic Minimed, Inc. | 2026-06-12 |
| Simplera and Simplera Sync (P160017/S137) | Medtronic Minimed, Inc. | 2026-05-26 |
| Simplera and Simplera Sync (P250012/S010) | Medtronic Minimed, Inc. | 2026-05-26 |
| Simplera Sync Sensor (P250012/S009) | Medtronic Minimed, Inc. | 2026-03-19 |