510(k) · Cleared
ClearedBiolinq 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
Cleared on Sep 18, 2026 as substantially equivalent to DEN240080 (Biolinq Incorporated, 2025) after a 53-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- Sep 18, 2026
- Review
- 53 days
- Class
- Class II
- Product code
- SFU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240080 (2025). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240080 Biolinq Shine Autonomous Time-in-Range MicrosensorBiolinq Incorporated · 2025
- This deviceK262599 Biolinq Shine Autonomous Time-in-Range MicrosensorBiolinq Incorporated · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240080 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | 2025 | — |
| 0 (this device) | K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | 2026 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN240080 | Biolinq Shine Autonomous Time-in-Range MicrosensorSummary page 5…tion Glucose range monitoring system Name Regulation Number 21 CFR 862.1359 Product Code SFU Legally Marketed Predicate Device(s) Predicate #: DEN240080 Predicate Trade Name: Biolinq Shine Autonomous Time-in-Range Sensor Product Code: SFU Device Description Summary Biolinq Shine A… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All SFU devicesSFU Glucose Range Monitoring System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 in persons 22 years or older not on insulin. The device may be used to aid in the…
Read the full statement (148 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 in persons 22 years or older not on insulin. The device may be used to aid in the management of a disease or condition related to glycemic control. 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/K262599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262599: Biolinq Shine Autonomous Time-in-Range Microsensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262599
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026