t:flex Insulin Delivery System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K143189 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 t:flex Insulin Delivery System is an insulin infusion pump designed for subcutaneous administration of insulin in diabetes management. Classified as an insulin pump, it delivers precise, programmable doses of insulin to help regulate blood glucose levels in patients with diabetes, supporting both basal and bolus insulin requirements.
This device is intended for single-use and requires FDA clearance under 510(k) as a Class II medical device. It is supplied sterile and is used in general hospital settings. The system includes multiple compatible cartridge and reservoir options, as referenced by the product codes (e.g., LZG). Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality, though specific MRI safety or reusable components are not indicated in the data.
Frequently asked questions
What is the t:flex Insulin Delivery System used for?
The t:flex Insulin Delivery System is designed for subcutaneous administration of insulin in diabetes management. It delivers programmable doses of insulin to help regulate blood glucose levels, supporting both basal (background) and bolus (meal-related) insulin requirements. This makes it suitable for patients requiring precise insulin control, particularly in clinical settings like hospitals.
Is the t:flex Insulin Delivery System single-use or reusable?
The t:flex Insulin Delivery System is intended for single-use only. This design ensures sterility and reduces the risk of contamination or cross-infection, which is particularly important in hospital environments where multiple patients may be managed. Single-use also aligns with regulatory requirements for insulin pumps under FDA 510(k) clearance.
How is the t:flex Insulin Delivery System supplied, and what sterility guarantees are included?
The t:flex Insulin Delivery System is supplied sterile, as required for medical devices intended for subcutaneous use. Sterility is critical to prevent infection and ensure patient safety. The system must be handled and stored according to the manufacturer’s guidelines to maintain its sterility and functionality throughout its intended use.
What cartridge or reservoir options are compatible with the t:flex Insulin Delivery System?
The t:flex Insulin Delivery System is compatible with multiple cartridge and reservoir options, each referenced by specific product codes (e.g., LZG). These options allow for flexibility in insulin dosing and administration based on patient needs. The exact compatibility details, including sizes and models, should be verified against the manufacturer’s documentation or product specifications.
Are there any special storage or handling instructions for the t:flex Insulin Delivery System?
While the t:flex Insulin Delivery System is supplied sterile, proper storage and handling are essential to preserve its functionality and sterility. The manufacturer provides guidelines for storage, which may include temperature control, protection from moisture, and avoiding exposure to contaminants. Adhering to these instructions ensures the device remains effective and safe for use in clinical settings.
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: Tandem Diabetes Care | Insulin Pumps for Diabetes Management, Investor Relations | Tandem Diabetes Care, Tandem Mobi Automated Insulin Delivery System Now Available in Twelve ..., Tandem Diabetes Care, Inc. Announces Tandem Mobi Automated Insulin ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143189 | Class II | Active |
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Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K143189 24 fields · synced Oct 6, 2026