Cleared Abbreviated

SONOSENS (K033193) - FDA 510(k) Clearance

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

K033193 · Friendly Sensors AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
113d
Days
Class 2
Risk

K033193 is an FDA 510(k) clearance for the SONOSENS. Classified as Goniometer With Electrodes (product code NKI), Class II - Special Controls.

Submitted by Friendly Sensors AG (Washington, US). The FDA issued a Cleared decision on January 23, 2004 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - 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.

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Submission Details

510(k) Number K033193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2003
Decision Date January 23, 2004
Days to Decision 113 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
35d faster than avg
Panel avg: 148d · This submission: 113d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NKI Goniometer With Electrodes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1500
Definition A Goniometer Is An Ac-powered Or Battery Powered Device Intended To Evaluate Joint Function By Measuring And Recording Range Of Motion, Acceleration, Or Forces Exerted By A Joint. The Class Ii (special Controls) Goniometer Uses Transcutaneous Adhesive Electrode Lead Wires And Patient Cables To Transmit And Record Patient Data.
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.