Cleared Traditional

K992129 - PHAZX VLD-100

K992129 is an FDA 510(k) clearance for PHAZX VLD-100, manufactured by Phazx Systems, Inc.. The device is a Class 2 Neurology device with product code GZO cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K992129 · Phazx Systems, Inc. · Neurology device
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Sep 1999
Decision
86d
Days
Class 2
Risk

K992129 is an FDA 510(k) clearance for the PHAZX VLD-100. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Phazx Systems, Inc. (Boulder, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K992129

510(k) Number K992129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1999
Decision Date September 17, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 149d · This submission: 86d
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 K992129.
MERIDIAN-II AND MERDIAN-PLUS
K001347 · Meridian Co., Ltd. · Nov 2000
MSAS PROFESSIONAL
K993824 · Biomeridian, Int. · Jan 2000
EIM-107 PREP-CHECK
K993202 · General Devices · Dec 1999
E-READER
K970436 · Natural Herbal Products, Inc. · Aug 1997
GALVANIC SKIN RESPONSE DEVICE
K943101 · Global Ent. · Oct 1995
DERMATRON SKIN RESISTANCE METER
K883112 · Raymar Electronics · Aug 1989
K992129 · PHAZX VLD-100
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