Cleared Traditional

K161245 - EP-TRACER System

K161245 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 94-day FDA review.

K161245 · Cardio Tek, BV · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
94d
Days
Class 2
Risk

K161245 is an FDA 510(k) clearance for the EP-TRACER System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Cardio Tek, BV (Ae Maastricht-Airport Limburg, NL). The FDA issued a Cleared decision on August 5, 2016 after a review of 94 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.

FDA 510(k) Submission Details - K161245

510(k) Number K161245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2016
Decision Date August 05, 2016
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 Consultant

Graematter, Inc.
MELISSA WALKER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 411
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K161245.
Sentry WEB SmartInterp
K153654 · Carefusion Germany 234 GmbH · Sep 2016
CardioConfirm
K161465 · Mortara Instrument, Inc. · Sep 2016
Rhythm View Workstation (non-streaming)
K161240 · Abbott Electrophysiology · Aug 2016
Merge Hemo
K152864 · Merge Healthcare Incorporated · Apr 2016
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
K152881 · Spacelabs Healthcare, Ltd. · Apr 2016
Navik 3D
K152160 · Apn Health, LLC · Feb 2016