Cleared Traditional

SMARTFLOW CATHETER (K123605) - FDA 510(k) Clearance

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

K123605 · Mri Interventions, Inc. · Neurology device
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Aug 2013
Decision
268d
Days
Class 2
Risk

K123605 is an FDA 510(k) clearance for the SMARTFLOW CATHETER. Classified as Catheter, Ventricular (product code HCA), Class II - Special Controls.

Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on August 16, 2013 after a review of 268 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4100 - 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.

View all Mri Interventions, Inc. devices

Submission Details

510(k) Number K123605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date August 16, 2013
Days to Decision 268 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
120d slower than avg
Panel avg: 148d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCA Catheter, Ventricular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4100
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.