Cleared Special

K000248 - CARTO EP NAVIGATION SYSTEM

K000248 is an FDA 510(k) clearance for CARTO EP NAVIGATION SYSTEM, manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 99-day FDA review.

K000248 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
99d
Days
Class 2
Risk

K000248 is an FDA 510(k) clearance for the CARTO 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 May 5, 2000 after a review of 99 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K000248

510(k) Number K000248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2000
Decision Date May 05, 2000
Days to Decision 99 days
Submission Type Special
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
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

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 437
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K000248.
ECHOCOM, IMAGECOM, DOKUCOM
K001592 · Tomtec Imaging Systems GmbH · Jun 2000
ENSITE 3000 SYSTEM, MODEL EE3000
K001437 · Endocardial Solutions, Inc. · Jun 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190 · Biosense Webster, Inc. · May 2000
NOGA CARDIAC NAVIGATION SYSTEM
K000332 · Biosense Webster, Inc. · May 2000
EP MEDSYSTEMS, EP-WORKMATE
K994011 · Ep Medsystems, Inc. · Mar 2000
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
K992703 · Premier Heart, LLC · Mar 2000
K000248 · CARTO EP NAVIGATION SYSTEM
Download PDF FDA Summary Biosense Webster, Inc.