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TD-4277 Blood Glucose Monitoring System, Model 4277

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100322

by Taidoc Technology Corporation

Identifiers

510(k) Number
K100322 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 TD-4277 Blood Glucose Monitoring System is a device intended for the quantitative measurement of blood glucose in fresh capillary whole blood or venous blood for professional use. It delivers precise glucose measurement in 5 seconds using only 0.5 µL of blood and features ketone warning, before- and after-meal flags, and 4 alarm reminder sets.

The system is designed for self-monitoring in healthcare and professional settings, with Bluetooth connectivity for data management. It allows for finger testing and alternative site testing. The device is supplied as a complete system and is intended for single-use applications. It has received FDA 510(k) clearance with the product code NBW.

Frequently asked questions

What is the TD-4277 Blood Glucose Monitoring System used for?

The TD-4277 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose in fresh capillary whole blood or venous blood for professional use. It delivers precise glucose measurement in 5 seconds using only 0.5 µL of blood.

What features does the TD-4277 Blood Glucose Monitoring System offer?

The system features ketone warning, before- and after-meal flags, and 4 alarm reminder sets. It is designed for self-monitoring in healthcare and professional settings, with Bluetooth connectivity for data management, and allows for finger testing and alternative site testing.

Is the TD-4277 Blood Glucose Monitoring System reusable or single-use?

The TD-4277 Blood Glucose Monitoring System is supplied as a complete system and is intended for single-use applications. This ensures hygiene and accuracy for each measurement.

What is the regulatory status of the TD-4277 Blood Glucose Monitoring System?

The TD-4277 Blood Glucose Monitoring System has received FDA 510(k) clearance with the product code NBW. This means it has been determined to be substantially equivalent to predicate devices already on the market.

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: Blood Glucose Meter TD-4277 | with Real-Time Alarms | TaiDoc, Digital Glucometer | Bluetooth connectivity | TaiDoc, TaiDoc TD-4277 GlucoRx Nexus - Medaval

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) K100322 24 fields · synced Oct 6, 2026