Cleared Traditional

K201518 - Route 92 Medical 088 Access System

K201518 is the FDA 510(k) clearance for Route 92 Medical 088 Access System by Route 92 Medical. It is a Class 2 Neurology device (product code QJP) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K201518 · Route 92 Medical · Neurology device
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Aug 2020
Decision
67d
Days
Class 2
Risk

K201518 is an FDA 510(k) clearance for the Route 92 Medical 088 Access System. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Route 92 Medical (San Mateo, US). The FDA issued a Cleared decision on August 14, 2020 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Route 92 Medical devices

Submission Details

510(k) Number K201518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2020
Decision Date August 14, 2020
Days to Decision 67 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
81d faster than avg
Panel avg: 148d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K201518.
BOSS 8F Balloon Guide Catheter
K203840 · Marblehead Medical, LLC · Jan 2021
Route 92 Medical 070 Access System
K203043 · Route 92 Medical, Inc. · Nov 2020
RIST Radial Access Catheter
K201682 · Rist Neurovascular, Inc. · Sep 2020
Anchor Dual Lumen Guidewire Catheter
K201076 · Aqure Medical, Inc. · Aug 2020
RIST Radial Access Catheter
K200417 · Rist Neurovascular, Inc. · May 2020
BOSS Balloon Guide Catheter
K200910 · Marblehead Medical · May 2020