510(k) DEN240080

Biolinq Shine Autonomous Time-in-Range Microsensor by Biolinq Incorporated — Product Code SFU

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: September 23, 2025
Date Received: December 27, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Glucose Range Monitoring System
Device Class: Class II
Regulation Number: 862.1359
Review Panel: CH
Submission Type

A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently. GRM systems are intended to support general user awareness of glucose ranges related to glycemic control. Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment.