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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Range Monitoring System
510(k) Number K262599
Device Name Biolinq Shine Autonomous Time-in-Range Microsensor
Applicant
Biolinq Incorporated
10260 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact Aly Alvarez
Correspondent
Biolinq Incorporated
10260 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact Aly Alvarez
Classification Product Code
SFU  
Date Received07/27/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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