Cleared Special

K092810 - EP-WORKMATE SYSTEM, VERSION 4.2

K092810 is an FDA 510(k) clearance for EP-WORKMATE SYSTEM, manufactured by St Jude Medical. 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.

K092810 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
28d
Days
Class 2
Risk

K092810 is an FDA 510(k) clearance for the EP-WORKMATE SYSTEM, VERSION 4.2. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by St Jude Medical (West Berlin, US). The FDA issued a Cleared decision on October 9, 2009 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.

FDA 510(k) Submission Details - K092810

510(k) Number K092810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2009
Decision Date October 09, 2009
Days to Decision 28 days
Submission Type Special
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
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 440
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K092810.
GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
K091781 · Mediguide, Ltd. · Oct 2009
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
K090017 · Biosense Webster, Inc. · Oct 2009
RADIANALYZER XPRESS
K092105 · Radi Medical Systems AB · Oct 2009
CARTO RMT EP NAVIGATION SYSTEM V8
K091789 · Biosense Webster, Inc. · Oct 2009
HORIZON XVU
K091165 · Mennen Medical , Ltd. · Aug 2009
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K091075 · iRhythm Technologies, Inc. · Jul 2009
K092810 · EP-WORKMATE SYSTEM, VERSION 4.2
Download PDF FDA Summary St Jude Medical