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Foracare GD20 Blood Glucose Monitoring System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K124040

by Taidoc Technology Corporation

Identifiers

510(k) Number
K124040 FDA 510(k)
FDA Product Code
NBW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Foracare GD20 Blood Glucose Monitoring System is a Blood Glucose Monitoring System (product code NBW) designed for the quantitative measurement of glucose in fresh whole blood samples. It falls under the Clinical Chemistry device classification and is intended for in vitro diagnostic use, specifically for self-testing by individuals managing diabetes.

This system is supplied for single-use, non-sterile applications in home settings and is regulated under FDA 510(k) clearance (K124040). It is intended for use with blood samples from the finger, palm, forearm, or upper arm and is classified as a Class II device under Special Controls. No MRI safety or reusable components are specified in the regulatory data.

Frequently asked questions

What types of blood samples can the Foracare GD20 monitor measure glucose from, and where on the body can I take these samples?

The Foracare GD20 is designed to measure glucose levels in fresh whole blood samples. It can be used with blood drawn from the finger, palm, forearm, or upper arm, making it convenient for self-testing at home.

Is the Foracare GD20 Blood Glucose Monitoring System intended for reuse or single-use, and is it sterile?

The Foracare GD20 is explicitly supplied for single-use only and is non-sterile, meaning it is intended for home use in non-clinical settings where sterile conditions are not required.

What regulatory pathway was followed for the FDA clearance of the Foracare GD20, and what classification does it hold?

The Foracare GD20 received FDA clearance through a Traditional 510(k) pathway (K124040) and is classified as a Class II device under Special Controls for Blood Glucose Monitoring Systems (product code NBW). It falls under the Clinical Chemistry advisory committee.

Is this device intended for professional medical use or self-testing by individuals managing diabetes?

The Foracare GD20 is specifically intended for self-testing by individuals managing diabetes in home settings, not for professional clinical use in hospitals or doctor’s offices.

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: FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM by TaiDoc Technology ..., K124040 FDA 510 (k) - FORACARE GD20 BLOOD GLUCOSE MONITORING ..., Foracare Gd20 Blood Glucose Monitoring System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Taidoc Technology Corporation

Sources (1)

  • FDA 510(k) K124040 24 fields · synced Oct 6, 2026