Cleared Traditional

K134044 - EP-TRACER SYSTEM

K134044 is an FDA 510(k) clearance for EP-TRACER SYSTEM, manufactured by Cardio Tek, BV. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K134044 · Cardio Tek, BV · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2014
Decision
90d
Days
Class 2
Risk

K134044 is an FDA 510(k) clearance for the EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Cardio Tek, BV (Ballwin, US). The FDA issued a Cleared decision on March 31, 2014 after a review of 90 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. 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. Standard predicate reliance. 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 Cardio Tek, BV devices

FDA 510(k) Submission Details - K134044

510(k) Number K134044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2013
Decision Date March 31, 2014
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 286
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K134044.
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