Omnipod Insulin Management System, Omnipod DASH Insulin Management System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182630 FDA 510(k)
- FDA Product Code
- LZG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Omnipod Insulin Management System is a tubeless, wearable insulin infusion pump designed for continuous subcutaneous insulin delivery in individuals with insulin-requiring diabetes. It eliminates the need for traditional pen injections or external tubing, providing a discreet and automated method of insulin administration.
The system is intended for single-use and is supplied as a reusable personal diabetes manager paired with disposable insulin pods. Authorized under FDA 510(k) and MDD regulations, it operates as a Class II medical device under product code LZG. The Omnipod DASH variant integrates a user-friendly interface for enhanced insulin management, adhering to general hospital medical specialty standards.
Frequently asked questions
What is the primary purpose of the Omnipod Insulin Management System and how does it differ from traditional insulin delivery methods?
The Omnipod Insulin Management System is designed for continuous subcutaneous insulin delivery in individuals with insulin-requiring diabetes. Unlike traditional pen injections or external tubing-based pumps, it is tubeless and wearable, providing a discreet, automated method of insulin administration without the need for external tubes or repeated injections.
Is the Omnipod system reusable or single-use, and what components are involved in its supply?
The Omnipod system consists of a reusable personal diabetes manager paired with disposable insulin pods. The insulin pods are intended for single-use, while the personal diabetes manager is designed to be reused across multiple pod replacements, ensuring convenience and cost-effectiveness over time.
What regulatory pathways have been followed for the Omnipod Insulin Management System, and what class does it fall under?
The Omnipod Insulin Management System has been authorized under both FDA 510(k) and MDD (Medical Device Directive) regulations. It is classified as a Class II medical device under product code LZG, with a decision of 'Substantially Equivalent' by the FDA’s General Hospital Orthopaedic Devices Advisory Committee.
Does the Omnipod DASH variant offer any additional features compared to the standard Omnipod system?
Yes, the Omnipod DASH variant integrates a user-friendly interface, which enhances insulin management capabilities. This interface is designed to improve usability and accessibility for users, aligning with general hospital medical specialty standards.
How should the Omnipod system be stored, and are there any specific handling instructions for the disposable components?
While the exact storage instructions are not detailed in the provided data, the system’s design—particularly the disposable insulin pods—implies they should be stored according to manufacturer guidelines to maintain sterility and functionality. The reusable personal diabetes manager should be cleaned and stored as directed to ensure proper operation and longevity. Always refer to the manufacturer’s instructions for precise storage and handling protocols.
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: Automatisierte Insulin-Dosierung leicht gemacht | Omnipod DE, Omnipod DASH | Insulin Pump Therapy | Omnipod, Home | Insulet, Omnipod® 5: Automatisierte Insulin-Dosierung leicht gemacht | Omnipod …
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182630 | Class II | Active |
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Manufacturer
- Manufacturer
- Insulet Corporation
Sources (2)
- FDA 510(k) K182630 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026