Cleared Traditional

K180201 - Route 92 Medical Access System

K180201 is an FDA 510(k) clearance for Route 92 Medical Access System, manufactured by Route 92 Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K180201 · Route 92 Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
119d
Days
Class 2
Risk

K180201 is an FDA 510(k) clearance for the Route 92 Medical Access System. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Route 92 Medical, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 23, 2018 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Route 92 Medical, Inc. devices

FDA 510(k) Submission Details - K180201

510(k) Number K180201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date May 23, 2018
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K180201.
WATCHMAN TruSeal Access System
K180864 · Boston Scientific · Jul 2018
React 68 Catheter
K180715 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2018
Phenom 27 Catheter
K180959 · Cathera, Inc. · Jun 2018
XableCath Support Catheter Product Family
K180986 · Xablecath, Inc. · May 2018
Wingman 35 Crossing Catheter
K173661 · Reflow Medical, Inc. · Apr 2018
Wedge Microcatheter
K172014 · MicroVention, Inc. · Apr 2018