Cleared Special

Route 92 Medical Full Length 088 Access System (K210635) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210635 · Route 92 Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
146d
Days
Class 2
Risk

K210635 is an FDA 510(k) clearance for the Route 92 Medical Full Length 088 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 July 27, 2021 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Route 92 Medical, Inc. devices

Submission Details

510(k) Number K210635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2021
Decision Date July 27, 2021
Days to Decision 146 days
Submission Type Special
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
2d faster than avg
Panel avg: 148d · This submission: 146d
Pathway characteristics
Modification to existing cleared device.

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 K210635.
AXS Vecta 46 Intermediate Catheter
K202752 · Stryker Neurovascular · Aug 2021
Balloon Guiding Catheter
K202916 · Shanghai Heartcare Medical Technology Co., Ltd. · Aug 2021
SelectFlex Neurovascular Access System Family
K211893 · Q'Apel Medical, Inc. · Aug 2021
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
K203764 · Imperative Care, Inc. · Mar 2021
BOSS 8F Balloon Guide Catheter
K203840 · Marblehead Medical, LLC · Jan 2021
Route 92 Medical 070 Access System
K203043 · Route 92 Medical, Inc. · Nov 2020