Not Cleared Direct

DEN240062 - Minder System (FDA 510(k) Clearance)

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

DEN240062 · Epi-Minder Pty, Ltd. · Neurology device
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Apr 2025
Decision
181d
Days
Class 2
Risk

DEN240062 is an FDA 510(k) submission (not cleared) for the Minder System. Classified as Sub-scalp Implanted Electroencephalogram System For Remote Patient Monitoring (product code SEM), Class II - Special Controls.

Submitted by Epi-Minder Pty, Ltd. (Melbourne, AU). The FDA issued a Not Cleared (DENG) decision on April 17, 2025 after a review of 181 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1360 - the FDA neurology device 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

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Submission Details

510(k) Number DEN240062 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 18, 2024
Decision Date April 17, 2025
Days to Decision 181 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 148d · This submission: 181d
Pathway characteristics

Device Classification

Product Code SEM Sub-scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1360
Definition A Sub-scalp Implanted Electroencephalogram (eeg) System For Remote Patient Monitoring Is A Prescription Device Used For Continuously Acquiring, Transmitting, And Storing Electrical Brain Activity Of Patients With Epilepsy. The Device Consists Of Sub-scalp Implanted Electrodes That Are Connected To A Transmitter Or Storage Device. The Device Is Used To Aid Clinicians In The Remote Monitoring Of Electrical Activity In The Patient’s Brain. The Device Is Not Intended To Be Implanted In Brain Tissue.
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 Neurology devices follow this clearance model.