Cleared Traditional

K262599 - Biolinq Shine Autonomous Time-in-Range Microsensor

K262599 is an FDA 510(k) clearance for Biolinq Shine Autonomous Time-in-Range ..., manufactured by Biolinq Incorporated. The device is a Class 2 Chemistry device with product code SFU cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K262599 · Biolinq Incorporated · Chemistry device
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Sep 2026
Decision
53d
Days
Class 2
Risk

K262599 is an FDA 510(k) clearance for the Biolinq Shine Autonomous Time-in-Range Microsensor. Classified as Glucose Range Monitoring System (product code SFU), Class II - Special Controls.

Submitted by Biolinq Incorporated (San Diego, US). The FDA issued a Cleared decision on September 18, 2026 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1359 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biolinq Incorporated devices

FDA 510(k) Submission Details - K262599

510(k) Number K262599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2026
Decision Date September 18, 2026
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SFU Device Classification - Class 2, Special Controls

Product Code SFU Glucose Range Monitoring System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1359
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.