Tandem Mobi insulin pump with interoperable technology
FDA 510(k) K253074 · Tandem Diabetes Care, Inc.
Submission
- Device name
- Tandem Mobi insulin pump with interoperable technology
- Applicant
- Tandem Diabetes Care, Inc.
San Diego, CA, US - Received
- September 23, 2025
- Decision date
- November 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFG – Alternate Controller Enabled Insulin Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5730
- Specialty
- 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…
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| K250798 | Control-IQ+ technologyQJI · Traditional | 05/21/2025SE |
| K243823 | Control-IQ+ technologyQJI · Traditional | 02/24/2025SE |
| K241078 | Tandem Mobi Insulin Pump with interoperable technologyQFG · Traditional | 07/26/2024SE |
| K240309 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | 03/21/2024SE |
| K232382 | Control-IQ TechnologyQJI · Traditional | 11/03/2023SE |
| K232380 | t:slim X2 Insulin Pump with Interoperable TechnologyQFG · Traditional | 11/03/2023SE |
| K233044 | Tandem Mobi insulin pump with interoperable technologyQFG · Special | 10/05/2023SE |
Questions and answers
When was Tandem Mobi insulin pump with interoperable technology cleared by the FDA?
Tandem Mobi insulin pump with interoperable technology (K253074) received a 510(k) decision of Substantially Equivalent on November 6, 2025, 44 days after the submission was received.
What is the product code of K253074?
The FDA product code is QFG – Alternate Controller Enabled Insulin Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 880.5730.