Cleared Abbreviated

K030517 - BALL RECORDING ELECTRODE/STIMULATION PROBE (FDA 510(k) Clearance)

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K030517 · Viasys Healthcare, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
163d
Days
Class 2
Risk

K030517 is an FDA 510(k) clearance for the BALL RECORDING ELECTRODE/STIMULATION PROBE. Classified as Electrode, Nasopharyngeal (product code GZK), Class II - Special Controls.

Submitted by Viasys Healthcare, Inc. (Stoughton, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 163 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1340 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Viasys Healthcare, Inc. devices

Submission Details

510(k) Number K030517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date August 01, 2003
Days to Decision 163 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 148d · This submission: 163d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GZK Electrode, Nasopharyngeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1340
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.