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Tandem Mobi Insulin Pump with Interoperable Technology

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241078

by Tandem Diabetes Care, Inc.

Identifiers

510(k) Number
K241078 FDA 510(k)
FDA Product Code
QFG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5730 FDA 510(k)
Regulation Number
880.5730 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tandem Mobi Insulin Pump with Interoperable Technology is an Alternate Controller Enabled Insulin Infusion Pump (per FDA classification QFG), designed for subcutaneous insulin delivery at programmable basal and bolus rates. It is intended for individuals with diabetes mellitus requiring insulin therapy, supporting automated or manual insulin administration to manage glycemic control. The device incorporates interoperable technology to integrate with external systems, enhancing its functionality for advanced diabetes management.

This pump is supplied as a reusable medical device, intended for clinical use in diabetes care settings. It is not classified as sterile and must be handled according to manufacturer guidelines for cleaning and maintenance. The device is regulated under FDA 510(k) clearance (K241078) and falls under the Clinical Chemistry advisory committee classification, adhering to regulatory standards for insulin infusion systems. Compatibility with specific continuous glucose monitoring (CGM) systems is noted in its interoperable design, though exact regulatory approvals for these integrations are referenced separately.

Frequently asked questions

What is the Tandem Mobi Insulin Pump with interoperable technology used for?

This device is designed for subcutaneous insulin delivery in individuals with diabetes mellitus requiring insulin therapy. It supports both automated and manual insulin administration to help manage glycemic control. The interoperable technology allows integration with external systems, such as compatible continuous glucose monitoring (CGM) devices, to enhance diabetes management capabilities.

Is the Tandem Mobi Insulin Pump reusable or single-use?

The Tandem Mobi Insulin Pump is a reusable medical device. It is intended for clinical use in diabetes care settings and must be handled according to the manufacturer’s guidelines for cleaning and maintenance to ensure proper functionality and safety.

Does the Tandem Mobi Insulin Pump come sterile?

No, the Tandem Mobi Insulin Pump is not classified as sterile. It is supplied for clinical use and must be cleaned and maintained as directed by the manufacturer to prevent contamination and ensure reliable performance.

What regulatory approval does the Tandem Mobi Insulin Pump hold?

The device holds FDA 510(k) clearance under the reference number K241078, classified as an Alternate Controller Enabled Insulin Infusion Pump (QFG). It adheres to regulatory standards for insulin infusion systems and is reviewed under the Clinical Chemistry advisory committee.

Can the Tandem Mobi Insulin Pump integrate with other diabetes management systems?

Yes, the pump incorporates interoperable technology to integrate with external systems, such as compatible continuous glucose monitoring (CGM) devices. This integration enhances its functionality for advanced diabetes management, though specific regulatory approvals for these integrations may vary and should be verified separately.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tandem Language Exchange App | Find Conversation Exchange …, Tandem Mobi Automated Insulin Delivery System | Tandem Diabetes Care, Tandem Mobi Insulin Pump Now Compatible with Dexcom G7 CGM | Tandem ..., Tandem Mobi, World's Smallest Durable Insulin Delivery System, Receives ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tandem Diabetes Care, Inc.

Sources (1)

  • FDA 510(k) K241078 24 fields · synced Oct 6, 2026