Cleared Traditional

EIM-107 PREP-CHECK (K993202) - FDA 510(k) Clearance

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

K993202 · General Devices · Neurology device
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Dec 1999
Decision
84d
Days
Class 2
Risk

K993202 is an FDA 510(k) clearance for the EIM-107 PREP-CHECK. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by General Devices (Ridgefield, US). The FDA issued a Cleared decision on December 17, 1999 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1540 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K993202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1999
Decision Date December 17, 1999
Days to Decision 84 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
64d faster than avg
Panel avg: 148d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZO Device, Galvanic Skin Response Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1540
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.