Alternate Controller Enabled Insulin Infusion Pump
FDA product code QFG · Class II (moderate risk) · 21 CFR 880.5730 · Clinical Chemistry
An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.
28510(k) clearances
0PMA approvals
21recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260001 | Mint ACE PumpQFG · Traditional | Beta Bionics, Inc. | 09/11/2026SE |
| K261672 | twiist Automated Insulin Delivery (AID) SystemQFG · Special | Deka Research and Development | 06/17/2026SE |
| K253976 | iLet ACE PumpQFG · Traditional | Beta Bionics, Inc. | 04/30/2026SE |
| K253743 | MiniMed Flex pumpQFG · Traditional | Medtronic Minimed, Inc. | 03/12/2026SE |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFG · Traditional | Medtronic Minimed, Inc. | 01/15/2026SE |
| K253074 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | Tandem Diabetes Care, Inc. | 11/06/2025SE |
| K252770 | iLet ACE PumpQFG · Special | Beta Bionics, Inc. | 09/29/2025SE |
| K250792 | t:slim X2 insulin pump with interoperable technologyQFG · Traditional | Tandem Diabetes Care, Inc. | 09/24/2025SE |
| K251032 | MiniMed 780G insulin pumpQFG · Traditional | Medtronic Minimed, Inc. | 07/01/2025SE |
| K250930 | twiist systemQFG · Special | Deka Research & Development Corp. | 04/02/2025SE |
| K234027 | embecta Insulin Delivery SystemQFG · Traditional | Embecta Medical I, LLC | 08/30/2024SE |
| K241078 | Tandem Mobi Insulin Pump with interoperable technologyQFG · Traditional | Tandem Diabetes Care, Inc. | 07/26/2024SE |
| K241178 | DEKA ACE Pump SystemQFG · Special | Deka Research and Development | 05/24/2024SE |
| K240309 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | Tandem Diabetes Care, Inc. | 03/21/2024SE |
| K233952 | DEKA ACE Pump SystemQFG · Traditional | Deka Research and Development | 03/13/2024SE |
| K230545 | Inessa SystemQFG · Traditional | Triple Jump Israel , Ltd. | 12/20/2023SE |
| K232380 | t:slim X2 Insulin Pump with Interoperable TechnologyQFG · Traditional | Tandem Diabetes Care, Inc. | 11/03/2023SE |
| K231826 | Omnipod 5 ACE PumpQFG · Traditional | Insulet Corporation | 10/18/2023SE |
| K233044 | Tandem Mobi insulin pump with interoperable technologyQFG · Special | Tandem Diabetes Care, Inc. | 10/05/2023SE |
| K213134 | Accu-Chek Solo micropump system with interoperable technologyQFG · Traditional | Roche Diabetes Care GmbH | 08/10/2023SE |
| K213536 | DEKA ACE Pump SystemQFG · Traditional | Deka Research and Development | 07/25/2023SE |
| K223213 | Tandem Mobi Insulin Pump with Interoperable TechnologyQFG · Traditional | Tandem Diabetes Care, Inc. | 07/10/2023SE |
| K231485 | iLet® ACE PumpQFG · Special | Beta Bionics, Inc. | 06/21/2023SE |
| K223846 | iLet® ACE PumpQFG · Traditional | Beta Bionics, Inc. | 05/19/2023SE |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)QFG · Traditional | Tandem Diabetes Care, Inc. | 02/15/2022SE |
| K203768 | Omnipod 5 ACE Pump (Pod)QFG · Traditional | Insulet Corporation | 01/27/2022SE |
| K201214 | t:slim X2 Insulin Pump with Interoperable TechnologyQFG · Special | Tandem Diabetes Care, Inc. | 06/04/2020SE |
| K191679 | Omnipod DASH Insulin Management System with interoperable technologyQFG · Traditional | Insulet Corporation | 09/20/2019SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2982-2026 Class II | MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLWLoaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump… | Medtronic MiniMed, Inc. | 07/13/2026Open, Classified |
| Z-2980-2026 Class II | MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump… | Medtronic MiniMed, Inc. | 07/13/2026Open, Classified |
| Z-2698-2026 Class II | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances… | Medtronic MiniMed, Inc. | 05/27/2026Open, Classified |
| Z-2603-2026 Class I | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2.…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | Insulet Corporation | 05/20/2026Open, Classified |
| Z-1996-2026 Class II | iLet Bionic Pancreas, REF: BB1001insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7… | Beta Bionics, Inc. | 03/12/2026Open, Classified |
| Z-1797-2026 Class I | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that… | Insulet Corporation | 03/12/2026Open, Classified |
| Z-1741-2026 Class II | MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be… | Medtronic MiniMed, Inc. | 02/13/2026Open, Classified |
| Z-1636-2026 Class II | Tandem pumps are battery-operated infusion pumps capable of both basal and bolus…The Czech language user guide contained multiple translation errors. The most significant error was that it… | Tandem Diabetes Care, Inc. | 01/30/2026Open, Classified |
| Z-1635-2026 Class II | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as… | Medtronic MiniMed, Inc. | 01/30/2026Open, Classified |
| Z-0427-2026 Class I | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated…Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions.… | Tandem Diabetes Care, Inc. | 10/06/2025Open, Classified |
| Z-2513-2026 Class II | iLet Bionic Pancreas, REF: BB1001The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous… | Beta Bionics, Inc. | 09/23/2025Open, Classified |
| Z-1809-2026 Class II | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Softwareit was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on… | Beta Bionics, Inc. | 08/13/2025Open, Classified |
| Z-0232-2026 Class II | t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF:…A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version… | Tandem Diabetes Care, Inc. | 08/05/2025Open, Classified |
| Z-2343-2025 Class I | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911…Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which… | Tandem Diabetes Care, Inc. | 07/21/2025Open, Classified |
| Z-2621-2025 Class II | t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing… | Tandem Diabetes Care, Inc. | 07/03/2025Open, Classified |
| Z-1520-2025 Class I | Tandem Mobi Insulin Pump with Interoperable TechnologyA software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used… | Tandem Diabetes Care, Inc. | 02/27/2025Open, Classified |
| Z-1519-2025 Class I | t:slim X2 Insulin Pump with Interoperable TechnologyA software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used… | Tandem Diabetes Care, Inc. | 02/27/2025Open, Classified |
| Z-1609-2024 Class I | t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ…During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating… | Tandem Diabetes Care, Inc. | 03/05/2024Open, Classified |
| Z-0591-2024 Class I | Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3…The bolus calculator is not recording the decimal point if it is the first value entered when changing a… | Insulet Corporation | 11/30/2023Open, Classified |
| Z-2618-2023 Class II | Omnipod 5 Automated Insulin Delivery SystemAn error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone… | Insulet Corporation | 02/28/2023Open, Classified |
| Z-0423-2023 Class II | Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM…The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and… | Insulet Corporation | 11/14/2022Open, Classified |