Cleared Traditional

K844659 - VPS 2250

K844659 is the FDA 510(k) clearance for VPS 2250 by Madsen Electronics (Canada) , Ltd.. It is a Class 2 Neurology device (product code GWE) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K844659 · Madsen Electronics (Canada) , Ltd. · Neurology device
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Feb 1985
Decision
91d
Days
Class 2
Risk

K844659 is an FDA 510(k) clearance for the VPS 2250, CSU2250 & VFU 2250. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Madsen Electronics (Canada) , Ltd. (Oakville, Ontario, CA). The FDA issued a Cleared decision on February 25, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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 Madsen Electronics (Canada) , Ltd. devices

Submission Details

510(k) Number K844659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1984
Decision Date February 25, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 16
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K844659.
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K842381 · Nihon Kohden America, Inc. · Nov 1984
BIOLOGIC SYSTEM BL 101
K831047 · Bio-Logic Systems Corp. · May 1983
STIMULATOR MODEL SSS-1101
K791149 · Nihon Kohden America, Inc. · Sep 1979