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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Ep Medsystems, Inc. devices

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 327
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K994011.
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190 · Biosense Webster, Inc. · May 2000
CARTO EP NAVIGATION SYSTEM
K000248 · Biosense Webster, Inc. · May 2000
NOGA CARDIAC NAVIGATION SYSTEM
K000332 · Biosense Webster, Inc. · May 2000
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