Cleared Traditional

K243199 - NightWatch+ US (FDA 510(k) Clearance)

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

K243199 · Livassured BV · Neurology device
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Optimized for regulatory review, auditing and printing
Jul 2025
Decision
284d
Days
Class 2
Risk

K243199 is an FDA 510(k) clearance for the NightWatch+ US. Classified as Physiological Signal Based Seizure Monitoring System (product code POS), Class II - Special Controls.

Submitted by Livassured BV (Leiden, NL). The FDA issued a Cleared decision on July 12, 2025 after a review of 284 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1580 - 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 K243199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 148d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POS Physiological Signal Based Seizure Monitoring System
Device Class Class 2 - 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.
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.