De Novo · Granted
GrantedEversense AP 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
Granted on Apr 29, 2024 as a new device type through De Novo after a 264-day review. 1 later device descends from it.
- Decided
- Apr 29, 2024
- Review
- 264 days
- Class
- Class II
- Product code
- SBA
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN230052 Eversense AP CGM SystemSenseonics, Incorporated · 2024
- Descendant · cites it directly · 0 of its ownK241335 Eversense 365 Continuous Glucose Monitoring (CGM) SystemSenseonics, Incorporated · 2024
Most influential descendants
Showing 1 of 1 · See all- K241335Eversense 365 Continuous Glucose Monitoring (CGM) SystemSenseonics, Incorporated · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230052 | Eversense AP CGM System | Senseonics, Incorporated | 2024 | — |
| +1 | K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 SBA? 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 SBA device
- #1 K241335 Eversense 365 Continuous Glucose Monitoring…score 8.0 · 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 |
|---|---|---|---|
| K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | 2024 | 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, K241335 (Senseonics, Incorporated, 2024) has gone furthest, with 0 descendants of its own.
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 AP CGM System is indicated for continually measuring glucose levels for up to 6 months in people (18 years and 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…
Read the full statement (159 words)
The Eversense AP CGM System is indicated for continually measuring glucose levels for up to 6 months in people (18 years and 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 AP CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense AP 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/DEN230052 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230052: Eversense AP CGM System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230052
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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