510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240080Unknown

Biolinq Shine Autonomous Time-in-Range Microsensor

Biolinq Incorporated, San Diego CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN240080 is the FDA 510(k) clearance record for Biolinq Shine Autonomous Time-in-Range Microsensor, a class II device, cleared for Biolinq Incorporated on under FDA product code SFU (Glucose Range Monitoring System). FDA's definition for product code SFU reads: "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...". FDA records list one 510(k) clearance for Biolinq Incorporated. As of , FDA records show no recalls naming DEN240080.

Clearance record

Decision date
Received
(270 days to decision)
Product code
SFU Glucose Range Monitoring System
Regulation
21 CFR 862.1359
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Biolinq Incorporated 10260 Sorrento Valley Rd., San Diego CA
Third party review
No

Clearances, product code SFU

Trailing 12 months
1 clearance under product code SFU in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SFU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260