Biolinq Shine Autonomous Time-in-Range Microsensor— 510(k) K262599
Substantially EquivalentBiolinq Incorporated
FDA 510(k) clearance K262599 for Biolinq Shine Autonomous Time-in-Range Microsensor, Substantially Equivalent on 2026-09-18. Applicant: Biolinq Incorporated. Device class: 2.
Summary
Biolinq Shine Autonomous Time-in-Range Microsensor is from Biolinq Incorporated, filed under product code SFU (Glucose Range Monitoring System). The record doesn't describe the sensor beyond its name and code.
Class II, 21 CFR 862.1359. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Biolinq filed from San Diego, California. The decision came 53 calendar days after FDA received it (July 27 to September 18, 2026).
Clearance details
- Applicant
- Biolinq Incorporated
- Product code
- Product code SFU
- Device class
- Class 2
- Regulation
- 21 CFR 862.1359
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code SFU
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