Cleared Traditional

K223733 - CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (FDA 510(k) Clearance)

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

K223733 · Biosense Webster, Inc. · Cardiovascular device
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Feb 2023
Decision
65d
Days
Class 2
Risk

K223733 is an FDA 510(k) clearance for the CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on February 16, 2023 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biosense Webster, Inc. devices

Submission Details

510(k) Number K223733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2022
Decision Date February 16, 2023
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 426
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K223733.
EnSite™ X EP System
K260212 · Abbott Medical · Apr 2026
ACORYS MAPPING SYSTEM
K253861 · Corify Care S.L · Apr 2026
Synchrony
K253473 · Stereotaxis, Inc. · Apr 2026
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3)
K254089 · Centerline Biomedical, Inc. · Feb 2026