Cleared Special

EpiMonitor

K250515 · Empatica S.R.L. · Neurology
Jun 2025
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K250515 is an FDA 510(k) clearance for the EpiMonitor, a Physiological Signal Based Seizure Monitoring System (Class II — Special Controls, product code POS), submitted by Empatica S.R.L. (Milano, IT). The FDA issued a Cleared decision on June 19, 2025, 118 days after receiving the submission on February 21, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1580.

Submission Details

510(k) Number K250515 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2025
Decision Date June 19, 2025
Days to Decision 118 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code POS — Physiological Signal Based Seizure Monitoring System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1580
Definition The Physiological Signal Based Seizure Monitoring System Is A Prescription Device That Uses Physiological Signal To Identify Abnormal Physiological Activity That May Be Associated With A Seizure. The System Does Not Predict Seizure Onsets, And Is Not Intended As A Standalone Seizure Monitoring Device.