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The Tracker / August 2026 / K260545

510(k) cleared

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System

Ascensia Diabetes Care · Aug 27, 2026 · K260545

FDA cleared the CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System from Ascensia Diabetes Care on Aug 27, 2026 under K260545, a traditional 510(k). The device falls under product code NBW, System, Test, Blood Glucose, Over The Counter, regulated at 21 CFR 862.1345 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Feb 18, 2026. The decision came 190 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ascensia Diabetes Care in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260545?

K260545 is the FDA 510(k) for CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System, submitted by Ascensia Diabetes Care. FDA's decision date was Aug 27, 2026, under product code NBW (System, Test, Blood Glucose, Over The Counter).

Who makes the CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System?

Ascensia Diabetes Care, based in Valhalla, NY, is the applicant of record for K260545.

How long did the K260545 review take?

FDA received the submission on Feb 18, 2026 and issued its decision on Aug 27, 2026, 190 days later.

← All decisions in August 2026