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CONTOUR NEXT ONE Blood Glucose Monitoring System

by Ascensia Diabetes Care

510(k) K160682

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 NumberK160682 Date17 Nov 2016ClearedStatusActive

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  • Withdrawn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, 21 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 CONTOUR NEXT ONE Blood Glucose Monitoring System is a blood glucose monitoring system designed for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. It is intended for use by people with diabetes at home or in clinical settings to aid in monitoring the effectiveness of diabetes control.

The system is supplied as a reusable meter with disposable test strips and a lancing device. It requires no sterilization as it is a non-invasive, external device. The device is authorized under FDA 510(k) clearance (K160682) and is classified under product code NBW. It is not indicated for MRI safety testing, and no sterility or single-use claims apply to the meter itself, which is intended for repeated use.

Other devices from Ascensia Diabetes Care

Questions

AI-generated answers, 21 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 CONTOUR NEXT ONE Blood Glucose Monitoring System used for?

    It is designed for the quantitative measurement of glucose in fresh capillary whole blood samples from the fingertip, palm, or forearm to help people with diabetes monitor the effectiveness of their diabetes control at home or in clinical settings.

  • How is the CONTOUR NEXT ONE system supplied and what components are included?

    The system is supplied as a reusable meter paired with disposable test strips and a lancing device; the meter itself is intended for repeated use and does not require sterilization as it is a non-invasive, external device.

  • Is the CONTOUR NEXT ONE meter sterile or single-use?

    No, the meter is not sterile and is not single-use; it is designed for repeated use over time, while only the test strips and lancets are disposable and intended for single use.