Cleared Traditional

K211438 - OPTRELL Mapping Catheter with TRUEref T...

K211438 is the FDA 510(k) clearance for OPTRELL Mapping Catheter with TRUEref T... by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code MTD) cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K211438 · Biosense Webster, Inc. · Cardiovascular device
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Mar 2022
Decision
312d
Days
Class 2
Risk

K211438 is an FDA 510(k) clearance for the OPTRELL Mapping Catheter with TRUEref Technology. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on March 18, 2022 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biosense Webster, Inc. devices

Submission Details

510(k) Number K211438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2021
Decision Date March 18, 2022
Days to Decision 312 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
187d slower than avg
Panel avg: 125d · This submission: 312d
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 24
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K211438.
Ablacath™ Mapping Catheter
K223666 · Ablacon, Inc. · Mar 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
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K201806 · Sterilmed Inc. (Johnson and Johnson) · Jun 2021
AcQMap 3D Imaging and Mapping Catheter
K201341 · Acutus Medical, Inc. · Sep 2020
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K200212 · Innovative Health, LLC · Sep 2020