Cleared Traditional

K023355 - ASYRA

K023355 is an FDA 510(k) clearance for ASYRA, manufactured by Galloway Technologies, LLC. The device is a Class 2 Neurology device with product code GZO cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K023355 · Galloway Technologies, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
260d
Days
Class 2
Risk

K023355 is an FDA 510(k) clearance for the ASYRA. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Galloway Technologies, LLC (Saratoga Springs, US). The FDA issued a Cleared decision on June 24, 2003 after a review of 260 days - an extended review 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: 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 - K023355

510(k) Number K023355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date June 24, 2003
Days to Decision 260 days
Submission Type Traditional
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
111d slower than avg
Panel avg: 149d · This submission: 260d
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 25
Devices cleared under the same product code (GZO) and FDA review panel - the closest regulatory comparables to K023355.
SUDOSCAN
K100233 · Impeto Medical · Jun 2010
MSAS-VANTAGE
K053004 · Biomeridian, Int. · Jan 2006
EPI-SCAN, MODEL P 100
K032935 · Edx Epi-Scan, Inc. · Nov 2003
ABR-2000
K020360 · Meridian Co., Ltd. · Aug 2002
AKUPORT M1
K020567 · Vibrant Health · May 2002
EAV KINDLING 2000S GSR DEVICE
K020564 · Virbrant Health · Apr 2002
K023355 · ASYRA
Download PDF FDA Summary Galloway Technologies…