De Novo · Granted
GrantedBiolinq Shine Autonomous Time-in-Range Microsensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolinq Incorporated · SFU Glucose Range Monitoring System
Granted on Sep 23, 2025 as a new device type through De Novo after a 270-day review. 1 later device descends from it.
- Decided
- Sep 23, 2025
- Review
- 270 days
- Class
- Class II
- Product code
- SFU
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN240080 Biolinq Shine Autonomous Time-in-Range MicrosensorBiolinq Incorporated · 2025
- Descendant · cites it directly · 0 of its ownK262599 Biolinq Shine Autonomous Time-in-Range MicrosensorBiolinq Incorporated · 2026
Most influential descendants
Showing 1 of 1 · See all- K262599Biolinq Shine Autonomous Time-in-Range MicrosensorBiolinq Incorporated · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN240080 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | 2025 | — |
| +1 | K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SFU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SFU device
- #1 K262599 Biolinq Shine Autonomous Time-in-Range…score 12.0 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K262599 (Biolinq Incorporated, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SFU devicesSFU Glucose Range Monitoring System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFU
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFU
Too few SFU 510(k)s in any year since 2007 to give a median.
Recalls per year · SFU
No recall names SFU since 2007.
Adverse event reports per year · SFU
No MAUDE report names SFU since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (143 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240080 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240080: Biolinq Shine Autonomous Time-in-Range Microsensor.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240080
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026