Cleared Traditional

K251792 - Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)

K251792 is an FDA 510(k) clearance for Stereotaxis GenesisX RMN with Navigant ..., manufactured by Stereotaxis, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K251792 · Stereotaxis, Inc. · Cardiovascular device
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Nov 2025
Decision
148d
Days
Class 2
Risk

K251792 is an FDA 510(k) clearance for the Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS). Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on November 6, 2025 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - 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 Stereotaxis, Inc. devices

FDA 510(k) Submission Details - K251792

510(k) Number K251792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2025
Decision Date November 06, 2025
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 27
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K251792.
GenesisX RMN
K262744 · Stereotaxis, Inc. · Aug 2026
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