510(k) K260545

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System by Ascensia Diabetes Care — Product Code NBW

K260545 is an FDA 510(k) premarket notification submitted by Ascensia Diabetes Care for the device "CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on August 27, 2026. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Ascensia Diabetes Care has at least 5 other 510(k) clearances on record.