Cleared Traditional

UROVAL BRS SYSTEM, MODEL BRS01 (K083679) - FDA 510(k) Clearance

Also marketed or referenced as:
TELESIS, MODEL PROMO1

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083679 · Uroval · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
274d
Days
Class 2
Risk

K083679 is an FDA 510(k) clearance for the UROVAL BRS SYSTEM, MODEL BRS01. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Uroval (Minneapolis, US). The FDA issued a Cleared decision on September 11, 2009 after a review of 274 days - an extended review cycle.

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.

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Submission Details

510(k) Number K083679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2008
Decision Date September 11, 2009
Days to Decision 274 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 148d · This submission: 274d
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.