Cleared Traditional

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 (K932571) - FDA 510(k) Clearance

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

K932571 · Tomey Corporation USA · Neurology device
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Aug 1995
Decision
826d
Days
Class 2
Risk

K932571 is an FDA 510(k) clearance for the TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on August 31, 1995 after a review of 826 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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 Tomey Corporation USA devices

Submission Details

510(k) Number K932571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1993
Decision Date August 31, 1995
Days to Decision 826 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
678d slower than avg
Panel avg: 148d · This submission: 826d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 48
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