Cleared Traditional

K141883 - CLINISCANSM EEG (FDA 510(k) Clearance)

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

K141883 · Picofemto, LLC · Neurology device
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May 2015
Decision
308d
Days
Class 2
Risk

K141883 is an FDA 510(k) clearance for the CLINISCANSM EEG. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Picofemto, LLC (New York, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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. Elevated predicate reliance profile. 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 Picofemto, LLC devices

Submission Details

510(k) Number K141883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2014
Decision Date May 15, 2015
Days to Decision 308 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 148d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User
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.

Regulatory Peers - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 40
Devices cleared under the same product code (OMB) and FDA review panel - the closest regulatory comparables to K141883.
Ceribell Infant Seizure Detection Software
K252070 · Ceribell, Inc. · Nov 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K252160 · Persyst Development, LLC · Oct 2025
Ceribell Seizure Detection Software
K241589 · Ceribell, Inc. · Apr 2025
autoSCORE (V 2.0.0)
K243743 · Holberg Eeg AS · Apr 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K242446 · Persyst Development Corporation · Jan 2025
NeuroMatch
K241390 · LVIS Corporation · Nov 2024