Cleared Traditional

EpiWatch Monitoring System

K243515 · Epiwatch, Inc. · Neurology
Mar 2025
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K243515 is an FDA 510(k) clearance for the EpiWatch Monitoring System, a Physiological Signal Based Seizure Monitoring System (Class II — Special Controls, product code POS), submitted by Epiwatch, Inc. (Baltimore, US). The FDA issued a Cleared decision on March 7, 2025, 114 days after receiving the submission on November 13, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1580.

Submission Details

510(k) Number K243515 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2024
Decision Date March 07, 2025
Days to Decision 114 days
Submission Type Traditional
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.