SFU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Glucose Range Monitoring System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1359
- Medical specialty
- Clinical Chemistry
- FDA definition
- A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently. GRM systems are intended to support general user awareness of glucose ranges related to glycemic control. Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment.
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| Record | Firm | Date |
|---|---|---|
| Biolinq Shine Autonomous Time-in-Range Microsensor (DEN240080) | Biolinq Incorporated | 2025-09-23 |
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