CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more— 510(k) K260545
Substantially EquivalentAscensia Diabetes Care
FDA 510(k) clearance K260545 for CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more, Substantially Equivalent on 2026-08-27. Applicant: Ascensia Diabetes Care. Device class: 2.
Summary
Ascensia Diabetes Care's submission covers three blood glucose monitoring systems: CONTOUR PLUS BLUE, CONTOUR NEXT GEN, and CONTOUR NEXT ONE. The product code is NBW, over-the-counter blood glucose test systems.
Class II, 21 CFR 862.1345. Clinical Chemistry is both the classification panel and the review panel. It came in as a Traditional 510(k).
Ascensia filed from Valhalla, New York. Review took 190 calendar days (February 18 to August 27, 2026) and ended in a substantially equivalent decision.
Clearance details
- Device name as filed
- CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System
- Applicant
- Ascensia Diabetes Care
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valhalla, NY, US
Recent devices under product code NBW
view all- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
- K260689 — CVS Advanced PLUS Blood Glucose Monitoring System
- K262116 — TRUE METRIX Self Monitoring Blood Glucose System
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K243060 — TeleRPM Gen2 Blood Glucose Monitoring System
More clearances from Ascensia Diabetes Care
view all- K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System
- K193407 — Contour® next GEN Blood Glucose Monitoring System
- K210687 — CONTOUR® NEXT ONE Blood Glucose Monitoring System
- K191286 — CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
- K160682 — CONTOUR NEXT ONE Blood Glucose Monitoring System
Adverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.