Cleared Traditional

Nelli (Version 7.11)

K251506 · Neuro Event Labs OY · Neurology
Nov 2025
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K251506 is an FDA 510(k) clearance for the Nelli (Version 7.11), a Physiological Signal Based Seizure Monitoring System (Class II — Special Controls, product code POS), submitted by Neuro Event Labs OY (Tampere, FI). The FDA issued a Cleared decision on November 21, 2025, 189 days after receiving the submission on May 16, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1580.

Submission Details

510(k) Number K251506 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2025
Decision Date November 21, 2025
Days to Decision 189 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.