Omnipod DASH Insulin Management System with Interoperable Technology
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191679 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 Omnipod DASH Insulin Management System with Interoperable Technology is an Alternate Controller Enabled Insulin Infusion Pump, designed for continuous subcutaneous insulin delivery in individuals with insulin-requiring diabetes. It operates as a tubeless, wearable device, eliminating the need for external tubing while providing automated insulin administration. The system integrates with external controllers to enhance interoperability and customization of insulin dosing based on user activity and glucose monitoring data.
This device is supplied as a reusable system with single-use insulin pods, intended for outpatient use in clinical chemistry settings. It is classified under FDA regulation 880.5730 and holds a Traditional 510(k) clearance (K191679) as substantially equivalent to a predicate device. The system is not MRI-safe and requires proper storage to maintain functionality, adhering to manufacturer guidelines for handling and disposal of components.
Frequently asked questions
What is the Omnipod DASH designed for?
The Omnipod DASH is an Alternate Controller Enabled Insulin Infusion Pump intended for continuous subcutaneous insulin delivery in individuals with insulin-requiring diabetes. It eliminates the need for external tubing by functioning as a tubeless, wearable device, while also allowing automated insulin administration. The system’s interoperability with external controllers enables customization of insulin dosing based on real-time glucose monitoring and user activity data.
How is the Omnipod DASH supplied, and what components are reusable or single-use?
The Omnipod DASH system is supplied as a reusable device, meaning the core pump unit can be reused across multiple treatments. However, insulin delivery is handled through single-use insulin pods, which must be replaced as needed. This design ensures hygiene and safety while maintaining the convenience of a reusable pump system.
Is the Omnipod DASH sterile, and how should it be stored?
The Omnipod DASH itself is not sterile out-of-the-box, but the single-use insulin pods are designed for clinical use in outpatient settings. Proper storage is critical to maintaining functionality. The manufacturer provides specific guidelines for handling, including temperature control and protection from moisture or physical damage, to ensure the device operates reliably when in use.
Can the Omnipod DASH be reused, and what are the implications for maintenance?
Yes, the Omnipod DASH system is reusable, meaning the pump unit can be used repeatedly with fresh insulin pods. However, reuse requires adherence to manufacturer instructions for cleaning, calibration, and maintenance to ensure accuracy and safety. Regular checks and proper handling are essential to prevent malfunctions or dosing errors over time.
Is the Omnipod DASH safe for MRI procedures, and what are its key limitations?
The Omnipod DASH is explicitly not MRI-safe, meaning it should not be used in or near MRI machines. This limitation is due to potential electromagnetic interference or mechanical damage from MRI fields. Users must avoid MRI environments entirely while wearing the device to prevent risks to both the device and the patient.
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: Omnipod DASH | Insulin Pump Therapy | Omnipod, Omnipod DASH® Insulin Management System | Omnipod, Home | Insulet, Omnipod DASH Insulin Management System with interoperable technology ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191679 | Class II | Active |
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Manufacturer
- Manufacturer
- Insulet Corporation
Sources (1)
- FDA 510(k) K191679 24 fields · synced Oct 1, 2026