510(k) DEN240080
DEN240080 is an FDA 510(k) premarket notification submitted by Biolinq Incorporated for the device "Biolinq Shine Autonomous Time-in-Range Microsensor". The FDA issued a decision of De Novo Granted on Sep 23, 2025. The device falls under product code SFU (Glucose Range Monitoring System), a Class II device regulated under 21 CFR 862.1359. Biolinq Incorporated has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Sep 23, 2025
- Date Received
- Dec 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.