Cleared Traditional

NightWatch+ US

K243199 · Livassured BV · Neurology
Jul 2025
Decision
284d
Days
Class 2
Risk

About This 510(k) Submission

K243199 is an FDA 510(k) clearance for the NightWatch+ US, a Physiological Signal Based Seizure Monitoring System (Class II — Special Controls, product code POS), submitted by Livassured BV (Leiden, NL). The FDA issued a Cleared decision on July 12, 2025, 284 days after receiving the submission on October 1, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1580.

Submission Details

510(k) Number K243199 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2024
Decision Date July 12, 2025
Days to Decision 284 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.