Not Cleared Direct

DEN230052 - Eversense AP CGM System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230052 · Senseonics, Incorporated · Chemistry device
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Apr 2024
Decision
264d
Days
Class 2
Risk

DEN230052 is an FDA 510(k) submission (not cleared) for the Eversense AP CGM System. Classified as Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (product code SBA), Class II - Special Controls.

Submitted by Senseonics, Incorporated (Germantown, US). The FDA issued a Not Cleared (DENG) decision on April 29, 2024 after a review of 264 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1357 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 264 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Senseonics, Incorporated devices

Submission Details

510(k) Number DEN230052 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 09, 2023
Decision Date April 29, 2024
Days to Decision 264 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 88d · This submission: 264d
Pathway characteristics

Device Classification

Product Code SBA Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1357
Definition An Integrated Continuous Glucose Monitoring System (icgm) With Sensor Containing Dexamethasone Acetate Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control. The Dexamethasone Acetate Coating Is Intended To Reduce Inflammation At The Sensor Insertion Site.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.