| 2026-06-17 |
K261672 |
Deka Research and Development
|
twiist Automated Insulin Delivery (AID) System |
| 2026-04-30 |
K253976 |
Beta Bionics, Inc.
|
iLet ACE Pump |
| 2026-03-12 |
K253743 |
Medtronic Minimed, Inc.
|
MiniMed Flex pump |
| 2026-01-15 |
K253470 |
Medtronic Minimed, Inc.
|
MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) |
| 2025-11-06 |
K253074 |
Tandem Diabetes Care, Inc.
|
Tandem Mobi insulin pump with interoperable technology |
| 2025-09-29 |
K252770 |
Beta Bionics, Inc.
|
iLet ACE Pump |
| 2025-09-24 |
K250792 |
Tandem Diabetes Care, Inc.
|
t:slim X2 insulin pump with interoperable technology |
| 2025-07-01 |
K251032 |
Medtronic Minimed, Inc.
|
MiniMed 780G insulin pump |
| 2025-04-02 |
K250930 |
Deka Research & Development Corp.
|
twiist system |
| 2024-08-30 |
K234027 |
Embecta Medical I, LLC
|
embecta Insulin Delivery System |
| 2024-07-26 |
K241078 |
Tandem Diabetes Care, Inc.
|
Tandem Mobi Insulin Pump with interoperable technology |
| 2024-05-24 |
K241178 |
Deka Research and Development
|
DEKA ACE Pump System |
| 2024-03-21 |
K240309 |
Tandem Diabetes Care, Inc.
|
Tandem Mobi insulin pump with interoperable technology |
| 2024-03-13 |
K233952 |
Deka Research and Development
|
DEKA ACE Pump System |
| 2023-12-20 |
K230545 |
Triple Jump Israel , Ltd.
|
Inessa System |
| 2023-11-03 |
K232380 |
Tandem Diabetes Care, Inc.
|
t:slim X2 Insulin Pump with Interoperable Technology |
| 2023-10-18 |
K231826 |
Insulet Corporation
|
Omnipod 5 ACE Pump |
| 2023-10-05 |
K233044 |
Tandem Diabetes Care, Inc.
|
Tandem Mobi insulin pump with interoperable technology |
| 2023-08-10 |
K213134 |
Roche Diabetes Care GmbH
|
Accu-Chek Solo micropump system with interoperable technology |
| 2023-07-25 |
K213536 |
Deka Research and Development
|
DEKA ACE Pump System |
| 2023-07-10 |
K223213 |
Tandem Diabetes Care, Inc.
|
Tandem Mobi Insulin Pump with Interoperable Technology |
| 2023-06-21 |
K231485 |
Beta Bionics, Inc.
|
iLet® ACE Pump |
| 2023-05-19 |
K223846 |
Beta Bionics, Inc.
|
iLet® ACE Pump |
| 2022-02-15 |
K203234 |
Tandem Diabetes Care, Inc.
|
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) |
| 2022-01-27 |
K203768 |
Insulet Corporation
|
Omnipod 5 ACE Pump (Pod) |