Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111669 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 device is a Freestyle glucose meter incorporated into the Omnipod insulin management systems. It is intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
The device is supplied as part of the Omnipod insulin management system for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. It has received FDA 510(k) clearance under K111669 and is classified as a Class II device with product code LZG.
Frequently asked questions
What is the Freestyle glucose meter incorporated into the Omnipod insulin management system used for?
It is intended for the quantitative measurement of glucose in fresh whole capillary blood from the finger, in vitro, to support diabetes management by providing blood glucose readings for insulin dosing decisions.
How is the Freestyle glucose meter supplied when used with the Omnipod system?
It is supplied as an integrated component of the Omnipod insulin management system, which is designed for subcutaneous delivery of insulin at set and variable rates for persons requiring insulin therapy.
Is the Freestyle glucose meter in the Omnipod system intended for single-use or reuse?
The glucose meter itself is designed for reuse as part of the durable Omnipod system, while the lancets and test strips used with it are single-use consumables for each blood glucose measurement.
What regulatory pathway was used for the Freestyle glucose meter in the Omnipod system?
The device received FDA 510(k) clearance under submission K111669, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device with product code LZG.
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: Freestyle Glucose Meter Incorporated Into the Omnipod Insulin ..., Freestyle Glucose Meter Incorporated Into the Omnipod Insulin ..., Home | FreeStyle Libre | Abbott, Freestyle Glucose Meter Incorporated Into The Omnipod Insulin ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111669 | Class II | Active |
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Manufacturer
- Manufacturer
- Insulet Corporation
Sources (1)
- FDA 510(k) K111669 24 fields · synced Sep 21, 2026