Devices descending from DEN180058
30 later devices reach t:slim X2 insulin pump with interoperable technology through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K213536 | DEKA ACE Pump System | Deka Research and Development | 2023 | 4 | — |
| +1 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2020 | 17 | Class I |
| +1 | K191679 | Omnipod DASH Insulin Management System with interoperable technology | Insulet Corporation | 2019 | 6 | — |
| +2 | K234027 | embecta Insulin Delivery System | Embecta Medical I, LLC | 2024 | 0 | — |
| +2 | K233952 | DEKA ACE Pump System | Deka Research and Development | 2024 | 3 | — |
| +2 | K230545 | Inessa System | Triple Jump Israel, Ltd. | 2023 | 0 | — |
| +2 | K213134 | Accu-Chek Solo micropump system with interoperable technology | Roche Diabetes Care GmbH | 2023 | 0 | — |
| +2 | K223846 | iLet® ACE Pump | Beta Bionics, Inc. | 2023 | 3 | — |
| +2 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | 2022 | 12 | Class I |
| +2 | K203768 | Omnipod 5 ACE Pump (Pod) | Insulet Corporation | 2022 | 2 | 2 |
| +3 | K250930 | twiist system | Deka Research & Development Corp. | 2025 | 1 | — |
| +3 | K241178 | DEKA ACE Pump System | Deka Research and Development | 2024 | 0 | — |
| +3 | K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | 6 | Class I |
| +3 | K231826 | Omnipod 5 ACE Pump | Insulet Corporation | 2023 | 1 | Class I |
| +3 | K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 | 4 | Class I |
| +3 | K231485 | iLet® ACE Pump | Beta Bionics, Inc. | 2023 | 2 | 1 |
| +4 | K260001 | Mint ACE Pump | Beta Bionics, Inc. | 2026 | 0 | — |
| +4 | K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | 2026 | 0 | — |
| +4 | K252770 | iLet ACE Pump | Beta Bionics, Inc. | 2025 | 1 | 2 |
| +4 | K250792 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025 | 0 | 1 |
| +4 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 4 | 6 |
| +4 | K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2023 | 3 | Class I |
| +5 | K253976 | iLet ACE Pump | Beta Bionics, Inc. | 2026 | 0 | — |
| +5 | K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | 2026 | 0 | 1 |
| +5 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026 | 1 | — |
| +5 | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | 2026 | 0 | — |
| +5 | K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024 | 2 | Class I |
| +6 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026 | 0 | — |
| +6 | K241078 | Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. | 2024 | 1 | Class I |
| +7 | K253074 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2025 | 0 | 1 |