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Glucoplus Blood Glucose Monitoring System

by Glucoplus, Inc.

510(k) K061234

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 NumberK061234 Date30 Oct 2006ClearedStatusActive

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  • Withdrawn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)

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, 27 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 Glucoplus Blood Glucose Monitoring System is a device used to measure glucose concentrations in whole blood. It provides quantitative results to assist individuals and healthcare professionals in monitoring blood glucose levels for diabetes management.

The system was cleared by the FDA through a traditional 510(k) pathway (K061234) as substantially equivalent to a predicate device, with product code NBW. It is identified as a monitoring system and is supplied by Glucoplus, Inc. under the authorization FDA_510K.

Questions

AI-generated answers, 27 Sep 2026

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

  • What type of sample does the Glucoplus system analyze?

    It analyzes whole blood samples to determine glucose concentration. Whole blood is the matrix specified in the device description, allowing users to obtain quantitative results directly from a finger‑stick or similar collection.

  • How is the Glucoplus Blood Glucose Monitoring System supplied to users?

    The system is supplied as a complete monitoring kit from Glucoplus, Inc. The description indicates it is provided by the manufacturer, implying that the device and any required accessories are packaged together for immediate clinical or personal use.

  • Is the Glucoplus monitor intended for single‑use or reusable applications?

    The data do not specify disposability, but blood glucose monitors are typically reusable devices that accept disposable test strips. Since only the system itself is described, it is reasonable to assume the monitor is reusable while the consumable strips are single‑use.

  • Are there multiple models or sizes available for this glucose monitoring system?

    The provided information lists only one product name without reference to additional models or size variations. Therefore, only a single model of the Glucoplus Blood Glucose Monitoring System is documented in the registry entry.

  • What regulatory pathway was used for the Glucoplus system's clearance?

    The device was cleared through the FDA's traditional 510(k) pathway (K061234), meaning it was found substantially equivalent to a predicate device. This pathway is noted in the description and confirms the regulatory route without implying any other status.