Cleared Special

CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM (K020863) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K020863 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
297d
Days
Class 2
Risk

K020863 is an FDA 510(k) clearance for the CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on January 9, 2003 after a review of 297 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biosense Webster, Inc. devices

Submission Details

510(k) Number K020863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date January 09, 2003
Days to Decision 297 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 125d · This submission: 297d
Pathway characteristics
Modification to existing cleared device.

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 427
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K020863.
ZEUS Platform (FG0501US)
K252859 · iRhythm Technologies, Inc. · May 2026
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