Cleared Traditional

K932533 - SMARTSCOPE

K932533 is an FDA 510(k) clearance for SMARTSCOPE, manufactured by Insight Medical Corp.. The device is a Class 2 Neurology device with product code JXE cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K932533 · Insight Medical Corp. · Neurology device
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Mar 1994
Decision
309d
Days
Class 2
Risk

K932533 is an FDA 510(k) clearance for the SMARTSCOPE. Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Insight Medical Corp. (Toronto, Ontario, CA). The FDA issued a Cleared decision on March 31, 1994 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K932533

510(k) Number K932533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date March 31, 1994
Days to Decision 309 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
161d slower than avg
Panel avg: 148d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXE Device Classification - Class 2, Special Controls

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
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.