Cleared Traditional

K262318 - Minder® System

K262318 is an FDA 510(k) clearance for Minder System, manufactured by Epi-Minder Pty, Ltd.. The device is a Class 2 Neurology device with product code SEM cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K262318 · Epi-Minder Pty, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
113d
Days
Class 2
Risk

K262318 is an FDA 510(k) clearance 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 Cleared decision on October 29, 2026 after a review of 113 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262318

510(k) Number K262318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2026
Decision Date October 29, 2026
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 149d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SEM Device Classification - Class 2, Special Controls

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.

K262318 · Minder® System
Download PDF FDA Summary Epi-Minder Pty, Ltd.