Medtronic Extended Infusion Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210544 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Extended Infusion Set is a subcutaneous infusion set designed for continuous subcutaneous insulin infusion, classified under the FDA product code FPA. It features a 90-degree soft cannula with an all-in-one insertion system, enabling prolonged wear for diabetes management. This device is intended for use with insulin pumps to deliver insulin therapy to patients with diabetes.
The infusion set is supplied sterile and intended for single-use only, adhering to FDA 510(k) clearance (K210544) under the General Hospital advisory committee. It is approved for wear durations of up to seven days, allowing for reduced site changes and improved patient comfort. Compatible with insulin pumps, it is regulated as a Class II medical device under the FDA’s traditional 510(k) pathway. Storage and handling must follow manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the Medtronic Extended Infusion Set used for?
The Medtronic Extended Infusion Set is designed for continuous subcutaneous insulin infusion in patients with diabetes. It connects to insulin pumps to deliver insulin therapy, reducing the need for frequent site changes and improving patient comfort by allowing wear for up to seven days.
How is the Medtronic Extended Infusion Set supplied and is it reusable?
The infusion set is supplied sterile and is intended for single-use only. This ensures patient safety and reduces the risk of infection or contamination associated with reuse, aligning with FDA guidelines for Class II medical devices.
What distinguishes the cannula design of this infusion set?
The infusion set features a 90-degree soft cannula, which is part of an all-in-one insertion system. This design is intended to facilitate easier and more comfortable insertion while maintaining stability during prolonged wear, up to seven days.
How should the Medtronic Extended Infusion Set be stored to maintain sterility?
Storage and handling must follow the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping the set in its original packaging until use and avoiding exposure to moisture, extreme temperatures, or contamination.
What regulatory pathway does this infusion set follow under FDA guidelines?
The Medtronic Extended Infusion Set is regulated as a Class II medical device under the FDA’s traditional 510(k) pathway. It received FDA clearance (K210544) under the General Hospital advisory committee, demonstrating substantial equivalence to a predicate device.
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: Infusion Sets | Medtronic, Extended™ Infusion Set and Reservoir | Medtronic, Extended™ Infusion Set and Reservoir | MiniMed - Medtronic Diabetes, Medtronic Extended™ infusion set | MiniMed, FDA warns insulin infusion set maker Unomedical over leaks, mishandled ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210544 | Class II | Active |
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Manufacturer
- Manufacturer
- Unomedical A/S
Sources (1)
- FDA 510(k) K210544 24 fields · synced Oct 1, 2026