FDA Product Code
FDA Product Code QFG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 880.5730
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260001 | Mint ACE Pump | Beta Bionics, Inc. | 2026-09-11 | Traditional | PDF ↗ |
| K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | 2026-06-17 | Special | PDF ↗ |
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | 2026-04-30 | Traditional | PDF ↗ |
| K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | 2026-03-12 | Traditional | PDF ↗ |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | 2026-01-15 | Traditional | PDF ↗ |
| K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-11-06 | Traditional | PDF ↗ |
| K252770 | iLet ACE Pump | Beta Bionics, Inc. | 2025-09-29 | Special | PDF ↗ |
| K250792 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025-09-24 | Traditional | PDF ↗ |
| K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025-07-01 | Traditional | PDF ↗ |
| K250930 | twiist system | Deka Research & Development Corp. | 2025-04-02 | Special | PDF ↗ |
| K234027 | embecta Insulin Delivery System | Embecta Medical I, LLC | 2024-08-30 | Traditional | PDF ↗ |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024-07-26 | Traditional | PDF ↗ |
| K241178 | DEKA ACE Pump System | Deka Research and Development | 2024-05-24 | Special | PDF ↗ |
| K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024-03-21 | Traditional | PDF ↗ |
| K233952 | DEKA ACE Pump System | Deka Research and Development | 2024-03-13 | Traditional | PDF ↗ |
| K230545 | Inessa System | Triple Jump Israel , Ltd. | 2023-12-20 | Traditional | PDF ↗ |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023-11-03 | Traditional | PDF ↗ |
| K231826 | Omnipod 5 ACE Pump | Insulet Corporation | 2023-10-18 | Traditional | PDF ↗ |
| K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2023-10-05 | Special | PDF ↗ |
| K213134 | Accu-Chek Solo micropump system with interoperable technology | Roche Diabetes Care GmbH | 2023-08-10 | Traditional | PDF ↗ |
| K213536 | DEKA ACE Pump System | Deka Research and Development | 2023-07-25 | Traditional | PDF ↗ |
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023-07-10 | Traditional | PDF ↗ |
| K231485 | iLet® ACE Pump | Beta Bionics, Inc. | 2023-06-21 | Special | PDF ↗ |
| K223846 | iLet® ACE Pump | Beta Bionics, Inc. | 2023-05-19 | Traditional | PDF ↗ |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | 2022-02-15 | Traditional | PDF ↗ |
| K203768 | Omnipod 5 ACE Pump (Pod) | Insulet Corporation | 2022-01-27 | Traditional | PDF ↗ |
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020-06-04 | Special | PDF ↗ |
| K191679 | Omnipod DASH Insulin Management System with interoperable technology | Insulet Corporation | 2019-09-20 | Traditional | PDF ↗ |
| DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019-02-14 | Direct | — |
Product code QFG · Class II · Clinical Chemistry. Data: openFDA.