FDA De Novo · Biolinq
DEN240080: Biolinq Shine Autonomous Time-in-Range Microsensor (Biolinq Incorporated)
Biolinq Incorporated received FDA De Novo DEN240080 for Biolinq Shine Autonomous Time-in-Range Microsensor, with a decision date of Sep 23, 2025.
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | DEN240080 |
|---|---|
| Pathway | De Novo |
| Applicant | Biolinq Incorporated |
| Device name | Biolinq Shine Autonomous Time-in-Range Microsensor |
| Product code | SFU: Glucose Range Monitoring System |
| Regulation (21 CFR) | 862.1359 |
| Device class | Class 2 |
| Date received | Dec 27, 2024 |
| Decision date | Sep 23, 2025 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions.
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 862.1359). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Our labels for filtering: claim Other, sensor Unknown. These are heuristics, not FDA fields.