510(k) · Cleared
ClearedEversense 365 Continuous Glucose Monitoring (CGM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senseonics, Incorporated · SBA Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Cleared on Sep 16, 2024 as substantially equivalent to DEN230052 (Senseonics, Incorporated, 2024) after a 126-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Sep 16, 2024
- Review
- 126 days
- Class
- Class II
- Product code
- SBA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230052 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230052 Eversense AP CGM SystemSenseonics, Incorporated · 2024
- This deviceK241335 Eversense 365 Continuous Glucose Monitoring (CGM) SystemSenseonics, Incorporated · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230052 | Eversense AP CGM System | Senseonics, Incorporated | 2024 | — |
| 0 (this device) | K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated | 2024 | — |
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 SBA? 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 |
|---|---|---|---|
| * | DEN230052 | Eversense AP CGM SystemSummary page 7…ing predicate devices was selected: Senseonics Eversense AP Continuous Glucose Monitoring (CGM) System by Senseonics, Incorporated authorized via DEN230052 The predicate device has been authorized by FDA for marketing in the US and has not been subject to a design-related recall.… | 2024 |
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 SBA devicesSBA Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SBA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SBA
Too few SBA 510(k)s in any year since 2007 to give a median.
Recalls per year · SBA
No recall names SBA since 2007.
Adverse event reports per year · SBA
1,162in 2025
MAUDE reports naming product code SBA, not matched to any one device; reports are not rates.
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 | 2 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 1,162 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Eversense 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 1 year in people (18 years or older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. The system is intended to: • Provide real-time glucose readings. • Provide glucose trend information. • Provide alerts for the detection and prediction of episodes…
Read the full statement (162 words)
The Eversense 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 1 year in people (18 years or older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.
The system is intended to:
• Provide real-time glucose readings.
• Provide glucose trend information.
• Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.
The Eversense 365 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense 365 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
The system is intended for single patient use and requires a prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241335: Eversense 365 Continuous Glucose Monitoring (CGM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241335
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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