Cleared Traditional

K932994 - EVOKED POTENTIAL SYSTEM-1.0

K932994 is an FDA 510(k) clearance for EVOKED POTENTIAL SYSTEM-1.0, manufactured by Neuromedical Systems, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 1032-day FDA review.

K932994 · Neuromedical Systems, Inc. · Neurology device
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Apr 1996
Decision
1032d
Days
Class 2
Risk

K932994 is an FDA 510(k) clearance for the EVOKED POTENTIAL SYSTEM-1.0. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Neuromedical Systems, Inc. (Chesterland, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 1032 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Neuromedical Systems, Inc. devices

FDA 510(k) Submission Details - K932994

510(k) Number K932994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1993
Decision Date April 15, 1996
Days to Decision 1032 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
884d slower than avg
Panel avg: 148d · This submission: 1032d
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 96
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K932994.
FOUR-CHANNEL PREAMPLIFIER
K962455 · Cadwell Laboratories, Inc. · Jan 1997
TWO-CHANNEL PREAMPLIFIER
K962457 · Cadwell Laboratories, Inc. · Jan 1997
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
K962458 · Cadwell Laboratories, Inc. · Jan 1997
ELECTROENCEPHALOGRAPH (EEG)
K960170 · Moberg Medical, Inc. · Mar 1996
SS102 DUAL CHANNEL SEP STIMULATOR
K955257 · Axon Systems, Inc. · Feb 1996
NEURONET
K952294 · Computational Diagnostics, Inc. · Jan 1996