Cleared Traditional

K950270 - NMI SOFTWARE

K950270 is an FDA 510(k) clearance for NMI SOFTWARE, manufactured by Nicolet Biomedical, Inc.. The device is a Class 2 Neurology device with product code OMB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K950270 · Nicolet Biomedical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
112d
Days
Class 2
Risk

K950270 is an FDA 510(k) clearance for the NMI SOFTWARE. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Nicolet Biomedical, Inc. (Madison, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 112 days - within the typical 510(k) review window.

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. 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 Nicolet Biomedical, Inc. devices

FDA 510(k) Submission Details - K950270

510(k) Number K950270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1995
Decision Date May 15, 1995
Days to Decision 112 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
36d faster than avg
Panel avg: 148d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMB Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (OMB) and FDA review panel - the closest regulatory comparables to K950270.
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
K010085 · Excel Tech. , Ltd. · Mar 2001
EEG SPIKE AND EVENT DETECTOR MODULE
K002332 · Excel Tech. , Ltd. · Oct 2000
BIO-LOGIC AUTOMATIC EVENT ANALYSIS
K951594 · Bio-Logic Systems Corp. · Aug 1995