Cleared Traditional

K952294 - NEURONET

K952294 is an FDA 510(k) clearance for NEURONET, manufactured by Computational Diagnostics, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K952294 · Computational Diagnostics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
255d
Days
Class 2
Risk

K952294 is an FDA 510(k) clearance for the NEURONET. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Computational Diagnostics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 255 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Computational Diagnostics, Inc. devices

FDA 510(k) Submission Details - K952294

510(k) Number K952294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1995
Decision Date January 26, 1996
Days to Decision 255 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 148d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 95
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K952294.
EVOKED POTENTIAL SYSTEM-1.0
K932994 · Neuromedical Systems, Inc. · Apr 1996
ELECTROENCEPHALOGRAPH (EEG)
K960170 · Moberg Medical, Inc. · Mar 1996
SS102 DUAL CHANNEL SEP STIMULATOR
K955257 · Axon Systems, Inc. · Feb 1996
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
K950208 · Nihon Kohden America, Inc. · May 1995
DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
K931923 · Dantec Medical, Inc. · Nov 1993
DANTEC MAGNETIC STIMULATOR MAGPRO
K926516 · Dantec Medical, Inc. · Aug 1993