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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
10d faster than avg
Panel avg: 149d · 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.

Regulatory Peers - GZO Device, Galvanic Skin Response Measurement

All 24
Devices cleared under the same product code (GZO) and FDA review panel - the closest regulatory comparables to K100233.
SUDO PATH
K131568 · Ld Technology, LLC · Jun 2013
ZYTO HAND CRADLE
K111308 · Zyto Technologies, Inc. · Aug 2011
ELECTRO INTERSTITIAL SCAN
K102166 · Ld Technology, LLC · Dec 2010
MSAS-VANTAGE
K053004 · Biomeridian, Int. · Jan 2006
EPI-SCAN, MODEL P 100
K032935 · Edx Epi-Scan, Inc. · Nov 2003
ASYRA
K023355 · Galloway Technologies, LLC · Jun 2003
K100233 · SUDOSCAN
Download PDF FDA Summary Impeto Medical