Cleared Traditional

K904222 - VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER

K904222 is an FDA 510(k) clearance for VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER, manufactured by Telediagnostic Systems, Inc.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K904222 · Telediagnostic Systems, Inc. · Neurology device
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Jan 1991
Decision
127d
Days
Class 2
Risk

K904222 is an FDA 510(k) clearance for the VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Telediagnostic Systems, Inc. (San Francisco, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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.

View all Telediagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K904222

510(k) Number K904222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1990
Decision Date January 18, 1991
Days to Decision 127 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 21
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K904222.
NEUROMETRIX BIOAMPLIFIER
K083322 · Neurometrix, Inc. · May 2009
SINGLE AMPLIFIER FOR BOTOX
K051852 · Allergan, Inc. · Sep 2005
SENSOR AMPLIFIER
K972515 · Pro-Tech Services, Inc. · Oct 1997
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · Nihon Kohden America, Inc. · Sep 1988
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · Nihon Kohden America, Inc. · Sep 1987
NICOLET AMP 6R11 SYSTEM
K871678 · Nicolet Biomedical Instruments · Jul 1987