Panels › Clinical Chemistry › Product code QFG · Class 2
Alternate Controller Enabled Insulin Infusion Pump
Regulation 880.5730
7510(k)s in 12 months (30 all time)
15recalls in 12 months (24 all time)
24recalls that name a 510(k)
Top companies in QFG
| Company | 510(k)s | Recalls |
|---|---|---|
| Tandem Diabetes Care, Inc. | 10 | 10 |
| Beta Bionics, Inc. | 6 | 3 |
| Medtronic Minimed, Inc. | 3 | 6 |
| Insulet Corporation | 3 | 5 |
| Deka Research and Development | 4 | 0 |
| Deka Research & Development Corp. | 1 | 0 |
| Embecta Medical I, LLC | 1 | 0 |
| Roche Diabetes Care GmbH | 1 | 0 |
| Triple Jump Israel , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K263422 | Mint ACE Pump Beta Bionics, Inc. | QFG |
| Sep 11, 2026 | K260001 | Mint ACE Pump Beta Bionics, Inc. | QFG |
| Jun 17, 2026 | K261672 | twiist Automated Insulin Delivery (AID) System Deka Research and Development | QFG |
| Apr 30, 2026 | K253976 | iLet ACE Pump Beta Bionics, Inc. | QFG |
| Mar 12, 2026 | K253743 | MiniMed Flex pump Medtronic Minimed, Inc. | QFG |
| Jan 15, 2026 | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) Medtronic Minimed, Inc. | QFG |
| Nov 6, 2025 | K253074 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Sep 29, 2025 | K252770 | iLet ACE Pump Beta Bionics, Inc. | QFG |
| Sep 24, 2025 | K250792 | t:slim X2 insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Jul 1, 2025 | K251032 | MiniMed 780G insulin pump Medtronic Minimed, Inc. | QFG |
| Apr 2, 2025 | K250930 | twiist system Deka Research & Development Corp. | QFG |
| Aug 30, 2024 | K234027 | embecta Insulin Delivery System Embecta Medical I, LLC | QFG |
| Jul 26, 2024 | K241078 | Tandem Mobi Insulin Pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| May 24, 2024 | K241178 | DEKA ACE Pump System Deka Research and Development | QFG |
| Mar 21, 2024 | K240309 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Mar 13, 2024 | K233952 | DEKA ACE Pump System Deka Research and Development | QFG |
| Dec 20, 2023 | K230545 | Inessa System Triple Jump Israel , Ltd., IL | QFG |
| Nov 3, 2023 | K232380 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. | QFG |
| Oct 18, 2023 | K231826 | Omnipod 5 ACE Pump Insulet Corporation | QFG |
| Oct 5, 2023 | K233044 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
| Aug 10, 2023 | K213134 | Accu-Chek Solo micropump system with interoperable technology Roche Diabetes Care GmbH, DE | QFG |
| Jul 25, 2023 | K213536 | DEKA ACE Pump System Deka Research and Development | QFG |
| Jul 10, 2023 | K223213 | Tandem Mobi Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. | QFG |
| Jun 21, 2023 | K231485 | iLet® ACE Pump Beta Bionics, Inc. | QFG |
| May 19, 2023 | K223846 | iLet® ACE Pump Beta Bionics, Inc. | QFG |
| Feb 15, 2022 | K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) Tandem Diabetes Care, Inc. | QFG |
| Jan 27, 2022 | K203768 | Omnipod 5 ACE Pump (Pod) Insulet Corporation | QFG |
| Jun 4, 2020 | K201214 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. | QFG |
| Sep 20, 2019 | K191679 | Omnipod DASH Insulin Management System with interoperable technology Insulet Corporation | QFG |
| Feb 14, 2019 | DEN180058 | t:slim X2 insulin pump with interoperable technology Tandem Diabetes Care, Inc. | QFG |
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