Cleared Special

K183266 - EP-TRACER System (FDA 510(k) Clearance)

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

K183266 · Schwarzer Cardiotek GmbH · Cardiovascular device
Mar 2019
Decision
98d
Days
Class 2
Risk

K183266 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 Schwarzer Cardiotek GmbH (Heilbronn, DE). The FDA issued a Cleared decision on March 1, 2019 after a review of 98 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.

Submission Details

510(k) Number K183266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2018
Decision Date March 01, 2019
Days to Decision 98 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
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 61
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K183266.
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3)
K254089 · Centerline Biomedical, Inc. · Feb 2026
Holter ECG and ABP system (HolterABP)
K251591 · Edan Instruments, Inc. · Feb 2026
SafeBeat Rx App
K251218 · Safebeat Rx, Inc. · Feb 2026
NorthStar™ Mapping System
K252164 · Imricor Medical Systems · Jan 2026