Cleared Traditional

K182180 - SPEAC System

K182180 is an FDA 510(k) clearance for SPEAC System, manufactured by Brain Sentinel, Inc.. The device is a Class 2 Neurology device with product code POS cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K182180 · Brain Sentinel, Inc. · Neurology device
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May 2019
Decision
271d
Days
Class 2
Risk

K182180 is an FDA 510(k) clearance for the SPEAC System. Classified as Physiological Signal Based Seizure Monitoring System (product code POS), Class II - Special Controls.

Submitted by Brain Sentinel, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 11, 2019 after a review of 271 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.

View all Brain Sentinel, Inc. devices

FDA 510(k) Submission Details - K182180

510(k) Number K182180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2018
Decision Date May 11, 2019
Days to Decision 271 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
123d slower than avg
Panel avg: 148d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

POS Device Classification - Class 2, Special Controls

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.