Cleared Special

K994011 - EP MEDSYSTEMS, EP-WORKMATE

K994011 is an FDA 510(k) clearance for EP MEDSYSTEMS, manufactured by Ep Medsystems, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 118-day FDA review.

K994011 · Ep Medsystems, Inc. · Cardiovascular device
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Mar 2000
Decision
118d
Days
Class 2
Risk

K994011 is an FDA 510(k) clearance for the EP MEDSYSTEMS, EP-WORKMATE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Ep Medsystems, Inc. (Mount Arlington, US). The FDA issued a Cleared decision on March 23, 2000 after a review of 118 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 - K994011

510(k) Number K994011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date March 23, 2000
Days to Decision 118 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
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 430
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K994011.
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NOGA CARDIAC NAVIGATION SYSTEM
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CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
K992703 · Premier Heart, LLC · Mar 2000
QMS MAPPING SYSTEM,MODEL 2000
K990058 · Cathdata, Inc. · Dec 1999
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K993729 · Biosense Webster, Inc. · Dec 1999
K994011 · EP MEDSYSTEMS, EP-WORKMATE
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