Cleared Traditional

K262068 - Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)

K262068 is an FDA 510(k) clearance for Khelix Magnetic Sensor Electrophysiolog..., manufactured by CathRx, Ltd.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K262068 · CathRx, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
109d
Days
Class 2
Risk

K262068 is an FDA 510(k) clearance for the Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG). Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by CathRx, Ltd. (Rydalmere, AU). The FDA issued a Cleared decision on October 9, 2026 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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.

FDA 510(k) Submission Details - K262068

510(k) Number K262068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2026
Decision Date October 09, 2026
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 Consultant

Acorn N Oakes, LLC
Amy Oakes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 185
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K262068.
Vision-MR™ Diagnostic Catheter
K252794 · Imricor Medical Systems, Inc. · Jan 2026
MAGiC Sweep™ EP Mapping Catheter
K250590 · Stereotaxis, Inc. · Jul 2025
VIKING™ Fixed Curve Diagnostic Catheter
K250310 · Boston Scientific Corporation · Jun 2025
EP•XT™ Unidirectional Steerable Diagnostic Catheter
K240366 · Boston Scientific Corporation · Nov 2024
Nordica PV Cryo Mapping Catheter
K233900 · Synaptic Medical Corporation · Sep 2024
Cosine-10TM Diagnostic Catheter
K233397 · Medtronic, Inc. · Dec 2023
K262068 · Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)
Download PDF FDA Summary CathRx, Ltd.