Cleared Traditional

K211438 - OPTRELL Mapping Catheter with TRUEref Technology

K211438 is an FDA 510(k) clearance for OPTRELL Mapping Catheter with TRUEref T..., manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K211438

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.

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 32
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