Cleared Traditional

K254181 - Aristotle 65 Macrowire

K254181 is an FDA 510(k) clearance for Aristotle 65 Macrowire, manufactured by Scientia Vascular. The device is a Class 2 Neurology device with product code MOF cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K254181 · Scientia Vascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
267d
Days
Class 2
Risk

K254181 is an FDA 510(k) clearance for the Aristotle 65 Macrowire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Scientia Vascular (West Valley City, US). The FDA issued a Cleared decision on September 16, 2026 after a review of 267 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - 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 Scientia Vascular devices

FDA 510(k) Submission Details - K254181

510(k) Number K254181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2025
Decision Date September 16, 2026
Days to Decision 267 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
118d slower than avg
Panel avg: 149d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOF Device Classification - Class 2, Special Controls

Product Code MOF Guide, Wire, Catheter, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - MOF Guide, Wire, Catheter, Neurovasculature

All 44
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K254181.
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