De Novo
DEN240080: Biolinq Shine Autonomous Time-in-Range Microsensor
FDA De Novo · biolinq incorporated · decided Sep 23, 2025
Key facts
| De Novo number | DEN240080 |
|---|---|
| Device name | Biolinq Shine Autonomous Time-in-Range Microsensor |
| Applicant | biolinq incorporated |
| Product code | SFU |
| Date received | Dec 27, 2024 |
| Decision date | Sep 23, 2025 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3025798257 |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: