Cleared Traditional

EKOS ULTRASOUND INFUSION SYSTEM (K041826) - FDA 510(k) Clearance

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

K041826 · Ekos Corp. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2005
Decision
294d
Days
Class 2
Risk

K041826 is an FDA 510(k) clearance for the EKOS ULTRASOUND INFUSION SYSTEM. Classified as Ultrasound, Infusion, System (product code NUI), Class II - Special Controls.

Submitted by Ekos Corp. (Bothell, US). The FDA issued a Cleared decision on April 27, 2005 after a review of 294 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1200 - 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 K041826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 07, 2004
Decision Date April 27, 2005
Days to Decision 294 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
146d slower than avg
Panel avg: 148d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUI Ultrasound, Infusion, System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Regional Infusion Of Contrast Materials Into Selected Vessels In The Neuro-vasculature. The Device May Be Used For Controlled, Regional Infusion Into Selected Vessels And Is Not Intended For Use In The Coronary Vasculature.
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.