Cleared Special

K263266 - Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set

K263266 is an FDA 510(k) clearance for Route 92 Medical Full Length 046 Reperf..., manufactured by Route 92 Medical, Inc.. The device is a Class 2 Neurology device with product code NRY cleared through the Special 510(k) pathway after a 28-day FDA review.

K263266 · Route 92 Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
28d
Days
Class 2
Risk

K263266 is an FDA 510(k) clearance for the Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Route 92 Medical, Inc. (San Mateo, US). The FDA issued a Cleared decision on October 16, 2026 after a review of 28 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K263266

510(k) Number K263266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2026
Decision Date October 16, 2026
Days to Decision 28 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
121d faster than avg
Panel avg: 149d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

NRY Device Classification - Class 2, Special Controls

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
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 - NRY Catheter, Thrombus Retriever

All 116
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K263266.
Toro 71 Aspiration Catheter
K262021 · Toro Neurovascular, Inc. · Oct 2026
Radical 064 Reperfusion Catheter
K261089 · Maduro Medical, Inc. · Sep 2026
Tigertriever 13 Ultra Revascularization Device
K260617 · Rapid Medical , Ltd. · Aug 2026
CEREGLIDE 57 Intermediate Catheter
K262398 · Cerenovus, Inc. · Aug 2026
APRO 35 Swift Catheter and Alembic Aspiration Tubing
K262391 · Alembic, LLC · Aug 2026
Millipede System
K262399 · Perfuze, Ltd. · Aug 2026
K263266 · Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
Download PDF FDA Summary Route 92 Medical, Inc.