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FDA 510(k)

Biolinq Shine Autonomous Time-in-Range Microsensor

K-Number: K262599 · 2026-09-18

ApplicantBiolinq Incorporated
Decision Date2026-09-18
Product CodeSFU
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Biolinq Shine Autonomous Time-in-Range Microsensor is the device name listed in this FDA 510(k) record. The listed applicant is Biolinq Incorporated. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K262599. The device is classified under product code SFU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biolinq Shine Autonomous Time-in-Range Microsensor?

Biolinq Shine Autonomous Time-in-Range Microsensor is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Biolinq Incorporated. The 510(k) number is K262599.

When did Biolinq Shine Autonomous Time-in-Range Microsensor receive FDA 510(k) clearance?

Biolinq Shine Autonomous Time-in-Range Microsensor received FDA 510(k) clearance on 2026-09-18, under 510(k) number K262599.

Who is the listed applicant for Biolinq Shine Autonomous Time-in-Range Microsensor?

The FDA 510(k) record lists Biolinq Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biolinq Shine Autonomous Time-in-Range Microsensor?

The FDA product code for Biolinq Shine Autonomous Time-in-Range Microsensor is SFU.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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