# Biolinq Shine Autonomous Time-in-Range Microsensor (K262599): 510(k) cleared for Biolinq Incorporated

**Predicate Speed & CAPA Advisory Opportunity Score:** 30/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262599 |
| Device | Biolinq Shine Autonomous Time-in-Range Microsensor |
| Applicant | Biolinq Incorporated |
| Specialty / panel | Clinical Chemistry |
| Product code | SFU |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-27 |
| Decision date | 2026-09-18 |
| Review time (days) | 53 |
| Third-party review | No |
| Applicant location | San Diego, CA, US |

## Why this score
- Fast 53-day review: this device is a strong predicate for similar products.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262599). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.