Cleared Special

K131568 - SUDO PATH

K131568 is an FDA 510(k) clearance for SUDO PATH, manufactured by Ld Technology, LLC. The device is a Class 2 Neurology device with product code GZO cleared through the Special 510(k) pathway after a 29-day FDA review.

K131568 · Ld Technology, LLC · Neurology device
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Jun 2013
Decision
29d
Days
Class 2
Risk

K131568 is an FDA 510(k) clearance for the SUDO PATH. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Ld Technology, LLC (Miami, US). The FDA issued a Cleared decision on June 28, 2013 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ld Technology, LLC devices

FDA 510(k) Submission Details - K131568

510(k) Number K131568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2013
Decision Date June 28, 2013
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 8
Devices cleared under the same product code (GZO) and FDA review panel - the closest regulatory comparables to K131568.
QBioScan
K150804 · Medeia, Inc. · Oct 2015
SudoC
K152216 · Ld Technology, LLC · Sep 2015
SUDOSCAN
K141872 · Impeto Medical, Inc. · Nov 2014
ZYTO HAND CRADLE
K111308 · Zyto Technologies, Inc. · Aug 2011
MSAS PROFESSIONAL
K993824 · Biomeridian, Int. · Jan 2000
EIM-107 PREP-CHECK
K993202 · General Devices · Dec 1999