510(k) K253743
- Device
- MiniMed Flex pump
- Applicant
- Medtronic Minimed, Inc.
- 510(k) number
- K253743
- Product code
- QFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-12
- Date received
- 2025-11-24
- Regulation
- 880.5730
- Classification name
- Alternate Controller Enabled Insulin Infusion Pump
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Omar Becerra
- Address
- 18000 Devonshire St. Northridge CA US 91325 91325
FDA Registration Numbers
- 3007981285
- 3044561902
- 3015192982
- 2029275
- 1220477
- 2219920
- 3016245399
- 2246552
- 2030598
- 1220973
- 3016540876
- 3032746481
- 3005627859
- 3026266833
- 3019807891
- 3013756811
- 3042027705
- 2030624
- 2032227
- 3030970576
- 3016798778
- 3019004087
- 3008824097
- 2032098
- 3014585508
- 3014197758
- 3010291427
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199150077380 | MiniMed Flex | MEDTRONIC MINIMED, INC. | 2026-05-25 |
| 00199150021031 | MiniMed Flex | MEDTRONIC MINIMED, INC. | 2026-05-24 |
Other 510(k) Records For Product Code QFG
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | 2026-04-30 |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | 2026-01-15 |
| K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-11-06 |
| K252770 | iLet ACE Pump | Beta Bionics, Inc. | 2025-09-29 |
| K250792 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-09-24 |
| K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025-07-01 |
| K250930 | twiist system | Deka Research & Development Corp. | 2025-04-02 |
| K234027 | embecta Insulin Delivery System | Embecta Medical I, LLC | 2024-08-30 |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024-07-26 |
| K241178 | DEKA ACE Pump System | Deka Research and Development | 2024-05-24 |
| K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024-03-21 |
| K233952 | DEKA ACE Pump System | Deka Research and Development | 2024-03-13 |
| K230545 | Inessa System | Triple Jump Israel , Ltd. | 2023-12-20 |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023-11-03 |
| K231826 | Omnipod 5 ACE Pump | Insulet Corporation | 2023-10-18 |