Cleared Traditional

FATIGMETER (K883914) - FDA 510(k) Clearance

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

K883914 · K. Jimbo Co., Inc. · Neurology device
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Oct 1989
Decision
410d
Days
Class 2
Risk

K883914 is an FDA 510(k) clearance for the FATIGMETER. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by K. Jimbo Co., Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 410 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 K. Jimbo Co., Inc. devices

Submission Details

510(k) Number K883914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1988
Decision Date October 31, 1989
Days to Decision 410 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 148d · This submission: 410d
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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