Cleared Traditional

Route 92 Medical 088 Access System, 110 cm (K200121) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200121 · Route 92 Medical, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2020
Decision
88d
Days
Class 2
Risk

K200121 is an FDA 510(k) clearance for the Route 92 Medical 088 Access System, 110 cm. 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 April 18, 2020 after a review of 88 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, Inc. devices

Submission Details

510(k) Number K200121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2020
Decision Date April 18, 2020
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 K200121.
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
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
K192804 · Medos International SARL · Feb 2020
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
K200206 · Stryker Neurovascular · Feb 2020