Cleared Traditional

UNEEG EpiSight System (K253607) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253607 · Uneeg Medical A/S · Neurology device
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Jun 2026
Decision
205d
Days
Class 2
Risk

K253607 is an FDA 510(k) clearance for the UNEEG EpiSight System. Classified as Sub-scalp Implanted Electroencephalogram System For Remote Patient Monitoring (product code SEM), Class II - Special Controls.

Submitted by Uneeg Medical A/S (Alleroed, DK). The FDA issued a Cleared decision on June 11, 2026 after a review of 205 days - an extended review cycle.

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.

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Submission Details

510(k) Number K253607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2025
Decision Date June 11, 2026
Days to Decision 205 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 148d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.