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Gluneo Blood Glucose Monitoring System

by Infopia Co, Ltd.

510(k) K130181

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130181 Date31 Jul 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring System
510(k) Number
FDA Product Code
NBW
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Gluneo Blood Glucose Monitoring System is a professional in vitro diagnostic device classified as a blood glucose meter (Product Code NBW). It measures capillary blood glucose levels using the GDH-FAD enzymatic method, providing quantitative results for diabetes management in clinical settings. Designed for multi-patient use, it supports monitoring of glycemic control in healthcare environments. The system is intended for external testing and does not require calibration adjustments.

This device is supplied as a reusable professional system, requiring single-use test strips and lancets for each measurement. It features automatic coding, a strip ejector, and a memory capacity of 500 test results. The system operates outside MRI environments and requires no special storage conditions beyond standard room temperature. FDA clearance (K130181) under the 510(k) pathway confirms its regulatory compliance for professional blood glucose monitoring in healthcare settings.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the Gluneo Blood Glucose Monitoring System designed for single-patient or multi-patient use in clinical settings?

    The Gluneo Blood Glucose Monitoring System is explicitly designed for multi-patient use in healthcare environments, such as hospitals or clinics. This makes it suitable for monitoring glycemic control across multiple patients rather than being limited to a single individual.

  • How many test results can the Gluneo device store, and does it require any calibration adjustments?

    The Gluneo system has a memory capacity of 500 test results, allowing clinicians to track glucose levels over extended periods. Unlike some meters, it does not require calibration adjustments, as it is designed for reliable, ready-to-use measurements using the GDH-FAD enzymatic method.

  • What type of consumables (test strips/lancets) are needed with the Gluneo, and are they reusable?

    The Gluneo system requires single-use test strips and lancets for each measurement—it is not designed for reusable consumables. This ensures accuracy and hygiene, as each strip and lancet is intended for one-time use only.

  • Can the Gluneo Blood Glucose Monitoring System be used in an MRI environment, and what storage conditions are required?

    The Gluneo system is not intended for use in MRI environments, as it is not MRI-compatible. For storage, it requires no special conditions beyond standard room temperature, making it convenient for clinical settings without climate-controlled requirements.