Orbit Infusion Set
FDA 510(k)Class II (US FDA 510(k))
by Ypsomed AG
Identifiers
- 510(k) Number
- K130468 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)
An infusion set is a device used for the subcutaneous delivery of fluids, such as insulin, from a pump to the body. The Orbit Infusion Set is a component designed for use with insulin pumps and automated insulin delivery systems.
It is supplied non-sterile and intended for single-use. The device is used in general hospital and home care settings. Authorization is based on FDA 510(k) clearance under product code FPA, with submission K130468. No claims regarding sterility, MRI safety, or specific sizes are made in the provided data.
Frequently asked questions
What is the Orbit Infusion Set used for?
The Orbit Infusion Set is used for the subcutaneous delivery of fluids, such as insulin, from an insulin pump or automated insulin delivery system to the body. It is designed as a component to connect the pump to the user for continuous fluid delivery in both home and hospital environments.
Is the Orbit Infusion Set sterile or non-sterile when supplied?
The Orbit Infusion Set is supplied non-sterile, as stated in the device data. It is intended for single-use, and no claims regarding sterility are made, meaning it should be handled according to user instructions to maintain appropriate hygiene before use.
Can the Orbit Infusion Set be reused after initial use?
No, the Orbit Infusion Set is intended for single-use only. Reuse is not recommended or supported by the provided data, as the device is designed to be discarded after one application to ensure safety and proper function in insulin delivery.
What regulatory pathway authorized the Orbit Infusion Set?
The Orbit Infusion Set received authorization through FDA 510(k) clearance, specifically under submission K130468. The clearance was based on a determination of substantial equivalence to a predicate device, with product code FPA assigned to the device.
In what settings is the Orbit Infusion Set intended to be used?
The Orbit Infusion Set is designed for use in both general hospital and home care settings. It supports subcutaneous insulin delivery for individuals using insulin pumps or automated insulin delivery systems, making it suitable for clinical and personal diabetes management environments.
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: mylife YpsoPump Orbit infusion sets, mylife - Orbit Infusion Sets, Ypsomed Orbit soft YpsoPump Infusion Set Manual, Orbit micro Infusion Set User Manual and Instructions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130468 | Class II | Active |
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Manufacturer
- Manufacturer
- Ypsomed AG
Sources (1)
- FDA 510(k) K130468 24 fields · synced Sep 24, 2026