Cleared Special

K070706 - EP-WORKMATE

K070706 is an FDA 510(k) clearance for EP-WORKMATE, manufactured by Ep Medsystems. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 28-day FDA review.

K070706 · Ep Medsystems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
28d
Days
Class 2
Risk

K070706 is an FDA 510(k) clearance for the EP-WORKMATE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Ep Medsystems (West Berlin, US). The FDA issued a Cleared decision on April 11, 2007 after a review of 28 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 devices

FDA 510(k) Submission Details - K070706

510(k) Number K070706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2007
Decision Date April 11, 2007
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
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 305
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K070706.
CARTO XP EP NAVIGATION SYSTEM, VERSION 9
K070240 · Biosense Webster, Inc. · May 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
K070902 · St Jude Medical · May 2007
HORIZON SE
K070254 · Mennen Medical , Ltd. · Apr 2007
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
K063490 · Spacelabs Medical, Inc. · Mar 2007
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · Ge Healthcare · Sep 2006
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
K053194 · Biosense Webster, Inc. · Mar 2006