510(k) K262599
K262599 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 Substantially Equivalent on Sep 18, 2026. 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
- SESE (Substantially Equivalent)
- Decision Date
- Sep 18, 2026
- Date Received
- Jul 27, 2026
- Clearance Type
- Traditional
- 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.