Cleared Traditional

K100233 - SUDOSCAN

K100233 is an FDA 510(k) clearance for SUDOSCAN, manufactured by Impeto Medical. The device is a Class 2 Neurology device with product code GZO cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K100233 · Impeto Medical · Neurology device
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Jun 2010
Decision
139d
Days
Class 2
Risk

K100233 is an FDA 510(k) clearance for the SUDOSCAN. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Impeto Medical (San Diego, US). The FDA issued a Cleared decision on June 14, 2010 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 - K100233

510(k) Number K100233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date June 14, 2010
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 148d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZO Device Classification - Class 2, Special Controls

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.