# DEN240080: Biolinq Shine Autonomous Time-in-Range Microsensor

- Pathway: De Novo (Direct)
- Applicant: Biolinq Incorporated
- Decided: Sep 23, 2025 after 270 days
- Product code: SFU (Glucose Range Monitoring System)
- Device class: 2
- Regulation: 21 CFR 862.1359
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K262599: Biolinq Shine Autonomous Time-in-Range Microsensor (2026), 0 descendants of its own

## Indications for use
Biolinq Shine Autonomous Time-in-Range Microsensor consists of a continuous intradermal glucose sensor with a color-changing indicator light. It is intended to measure, record, and analyze physiologic data using an array of microsensors combined with an accelerometer and ambient light sensor. The qualitative display communicates real-time changes in glucose levels to aid in the management of a disease or condition related to glycemic control in persons 22 years or older not on insulin. An app provides more granular glucose information. It analyzes and correlates this glucose information with meals, rest, and activity levels. Use of the glucose and activity information is designed to facilitate acute behavior and lifestyle modifications. Interpretation of device readings should be based on glucose and activity trends and patterns. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

Source page: https://510kreport.com/device/DEN240080
Methodology: https://510kreport.com/methodology