Cleared Traditional

K853804 - VICON (MODIFICATION)

K853804 is the FDA 510(k) clearance for VICON (MODIFICATION) by Oxford Metrics, Inc.. It is a Class 2 Neurology device (product code IKN) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K853804 · Oxford Metrics, Inc. · Neurology device
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Dec 1985
Decision
107d
Days
Class 2
Risk

K853804 is an FDA 510(k) clearance for the VICON (MODIFICATION). Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Oxford Metrics, Inc. (Clearwater, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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 Oxford Metrics, Inc. devices

Submission Details

510(k) Number K853804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1985
Decision Date December 27, 1985
Days to Decision 107 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 148d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 13
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K853804.
PHASIS ELECTROMYOGRAPH
K922488 · Biosound, Inc. · Mar 1993
EMG NAVIGATOR & EMG TRAVELER
K893130 · Bio-Logic Systems Corp. · Mar 1990
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · Nihon Kohden America, Inc. · Jan 1983
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K822624 · Del Mar Avionics · Oct 1982
ANESTHESIA & BRAIN MONITOR
K821910 · Datex Division Instrumentarium Corp. · Sep 1982