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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K262599

510(k) cleared

Biolinq Shine Autonomous Time-in-Range Microsensor

Biolinq Incorporated · Sep 18, 2026 · K262599 · In the directory

FDA cleared the Biolinq Shine Autonomous Time-in-Range Microsensor from Biolinq Incorporated on Sep 18, 2026 under K262599, a traditional 510(k). The device falls under product code SFU, Glucose Range Monitoring System, regulated at 21 CFR 862.1359 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jul 27, 2026. The decision came 53 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Biolinq Incorporated in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262599?

K262599 is the FDA 510(k) for Biolinq Shine Autonomous Time-in-Range Microsensor, submitted by Biolinq Incorporated. FDA's decision date was Sep 18, 2026, under product code SFU (Glucose Range Monitoring System).

Who makes the Biolinq Shine Autonomous Time-in-Range Microsensor?

Biolinq Incorporated, based in San Diego, CA, is the applicant of record for K262599. The company is listed in the MedDevice Startups directory.

How long did the K262599 review take?

FDA received the submission on Jul 27, 2026 and issued its decision on Sep 18, 2026, 53 days later.

← All decisions in September 2026

Sources

In the startup directory

Biolinq

Diabetes & Metabolic · San Diego, CA