Cleared Traditional

K042681 - CARTO RMT EP NAVIGATION SYSTEM

K042681 is an FDA 510(k) clearance for CARTO RMT EP NAVIGATION SYSTEM, manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K042681 · Biosense Webster, Inc. · Cardiovascular device
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Sep 2005
Decision
365d
Days
Class 2
Risk

K042681 is an FDA 510(k) clearance for the CARTO RMT 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 September 29, 2005 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 - K042681

510(k) Number K042681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date September 29, 2005
Days to Decision 365 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
240d slower than avg
Panel avg: 125d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 359
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K042681.
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
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DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
K052977 · Ge Healthcare · Nov 2005
MARS HOLTER ANALYSIS WORKSTATION
K051026 · Ge Medical Systems Information Technologies · Jul 2005
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K050093 · Ge Medical Systems Information Technologies · May 2005
WINDSURFER
K050561 · Medcon , Ltd. · May 2005