# DEN230052: Eversense AP CGM System

- Pathway: De Novo (Direct)
- Applicant: Senseonics, Incorporated
- Decided: Apr 29, 2024 after 264 days
- Product code: SBA (Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate)
- Device class: 2
- Regulation: 21 CFR 862.1357
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K241335: Eversense 365 Continuous Glucose Monitoring (CGM) System (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN230052
Methodology: https://510kreport.com/methodology