Dario Blood Glucose Monitoring System— 510(k) K163159

Substantially Equivalent

Labstyle Innovations, Ltd.

FDA 510(k) clearance K163159 for Dario Blood Glucose Monitoring System, Substantially Equivalent on 2017-07-19. Applicant: Labstyle Innovations, Ltd..

Clearance details

Applicant: Labstyle Innovations, Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2016-11-10
Decision date: 2017-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.