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Ascensia Breeze Blood Glucose Meter

by Bayer Corp.

510(k) K024062

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 NumberK024062 Date3 Mar 2003ClearedStatusActive

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  • Withdrawn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
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Ascensia Breeze Blood Glucose Meter is a device used to measure blood glucose levels. It is designed to work with the Ascensia Autodisc Unique 10-Test Disc. The device provides a reading of the user's blood glucose level, which can be used to manage diabetes. The meter displays the result, and if an error occurs, it may show 'HI', indicating that the test should be repeated.

The Ascensia Breeze Blood Glucose Meter is supplied with a user manual and is intended for use by individuals with diabetes. The device is regulated under product code CGA and has a regulation number of 862.1345. It has been cleared by the FDA under the traditional clearance type, with a decision code of SESE. The device is used in clinical chemistry settings and is designed for single-use test strips, with a countdown display after the test is complete.

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Questions

AI-generated answers, 22 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 is the Ascensia Breeze Blood Glucose Meter used for?

    The Ascensia Breeze Blood Glucose Meter is used to measure blood glucose levels, helping individuals with diabetes manage their condition.

  • How is the Ascensia Breeze Blood Glucose Meter supplied?

    The device is supplied with a user manual, intended for use by individuals with diabetes, and is designed to work with the Ascensia Autodisc Unique 10-Test Disc.

  • Is the Ascensia Breeze Blood Glucose Meter for single-use or reuse?

    The device is designed for single-use test strips, with a countdown display after the test is complete.

  • What regulatory classification does the Ascensia Breeze Blood Glucose Meter have?

    The device is regulated under product code CGA and has a regulation number of 862.1345.