Cleared Special

K262744 - GenesisX RMN

K262744 is an FDA 510(k) clearance for GenesisX RMN, manufactured by Stereotaxis, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Special 510(k) pathway after a 24-day FDA review.

K262744 · Stereotaxis, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
24d
Days
Class 2
Risk

K262744 is an FDA 510(k) clearance for the GenesisX RMN. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 27, 2026 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - the FDA cardiovascular device oversight 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 - K262744

510(k) Number K262744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2026
Decision Date August 27, 2026
Days to Decision 24 days
Submission Type Special
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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
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 - DXX System, Catheter Control, Steerable

All 33
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K262744.
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
K251792 · Stereotaxis, Inc. · Nov 2025
LIBERTY Endovascular Robotic System (LIBERTYOS)
K243789 · Microbot Medical , Ltd. · Sep 2025
CorPath GRX System
K221464 · Corindus, Inc. · Jul 2022
CorPath GRX System
K202275 · Corindus, Inc. · Dec 2020
CorPath GRX System
K180517 · Corindus, Inc. · Mar 2018
CorPath GRX System
K173806 · Corindus, Inc. · Mar 2018
K262744 · GenesisX RMN
Download PDF FDA Summary Stereotaxis, Inc.