Cleared Traditional

K083679 - UROVAL BRS SYSTEM, MODEL BRS01

Also marketed or referenced as:
TELESIS, MODEL PROMO1

K083679 is an FDA 510(k) clearance for UROVAL BRS SYSTEM, manufactured by Uroval. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K083679 · Uroval · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K083679

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 149d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

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 71
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K083679 · UROVAL BRS SYSTEM, MODEL BRS01
Download PDF FDA Summary Uroval