Cleared Special

K261012 - OptiMap Catheter - 60mm (OPTI-CATH2-60)

K261012 is an FDA 510(k) clearance for OptiMap Catheter - 60mm (OPTI-CATH2-60), manufactured by Cortex, Inc.. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Special 510(k) pathway after a 27-day FDA review.

K261012 · Cortex, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
27d
Days
Class 2
Risk

K261012 is an FDA 510(k) clearance for the OptiMap Catheter - 60mm (OPTI-CATH2-60). Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Cortex, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 23, 2026 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 - K261012

510(k) Number K261012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2026
Decision Date April 23, 2026
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

MTD Device Classification - Class 2, Special Controls

Product Code MTD Catheter, Intracardiac Mapping, High-density Array
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 Peers - MTD Catheter, Intracardiac Mapping, High-density Array

All 33
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K261012.
OptiMap Catheter - 50mm (OPTI-CATH2-50)
K253205 · Cortex, Inc. · Mar 2026
Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · Medtronic · Aug 2024
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
K241372 · Abbott Medical · Jul 2024
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
K231312 · Biosense Webster, Inc. · Jul 2023
Ablacath™ Mapping Catheter
K223666 · Ablacon, Inc. · Mar 2023
OPTRELL™ Mapping Catheter with TRUEref™ Technology
K230253 · Biosense Webster, Inc. · Mar 2023
K261012 · OptiMap Catheter - 60mm (OPTI-CATH2-60)
Download PDF FDA Summary Cortex, Inc.