Cleared Traditional

K253205 - OptiMap Catheter - 50mm (OPTI-CATH2-50) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253205 · Cortex, Inc. · Cardiovascular device
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Mar 2026
Decision
168d
Days
Class 2
Risk

K253205 is an FDA 510(k) clearance for the OptiMap Catheter - 50mm (OPTI-CATH2-50). 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 March 13, 2026 after a review of 168 days - an extended review cycle.

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.

View all Cortex, Inc. devices

Submission Details

510(k) Number K253205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2025
Decision Date March 13, 2026
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K253205.
OptiMap Catheter - 60mm (OPTI-CATH2-60)
K261012 · Cortex, Inc. · Apr 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
OPTRELL™ Mapping Catheter with TRUEref™ Technology
K230253 · Biosense Webster, Inc. · Mar 2023
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K210766 · Acutus Medical, Inc. · Jun 2022