Cleared Traditional

K254006 - Drivewire 35 Guidewire

K254006 is the FDA 510(k) clearance for Drivewire 35 Guidewire by Rapid Medical , Ltd.. It is a Class 2 Neurology device (product code MOF) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K254006 · Rapid Medical , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
214d
Days
Class 2
Risk

K254006 is an FDA 510(k) clearance for the Drivewire 35 Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Rapid Medical , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on July 17, 2026 after a review of 214 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 Rapid Medical , Ltd. devices

Submission Details

510(k) Number K254006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2025
Decision Date July 17, 2026
Days to Decision 214 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
66d slower than avg
Panel avg: 148d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
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