Cleared Traditional

K260220 - Route 92 Medical Full Length 046 Access System

K260220 is an FDA 510(k) clearance for Route 92 Medical Full Length 046 Access..., manufactured by Route 92 Medical, Inc.. The device is a Class 2 Neurology device with product code QJP cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K260220 · Route 92 Medical, Inc. · Neurology device
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Sep 2026
Decision
233d
Days
Class 2
Risk

K260220 is an FDA 510(k) clearance for the Route 92 Medical Full Length 046 Access System. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Route 92 Medical, Inc. (San Mateo, US). The FDA issued a Cleared decision on September 16, 2026 after a review of 233 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - 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 Route 92 Medical, Inc. devices

FDA 510(k) Submission Details - K260220

510(k) Number K260220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2026
Decision Date September 16, 2026
Days to Decision 233 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
84d slower than avg
Panel avg: 149d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJP Device Classification - Class 2, Special Controls

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 - QJP Catheter, Percutaneous, Neurovasculature

All 99
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K260220.
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