Cleared Special

K092913 - EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04

K092913 is an FDA 510(k) clearance for EP-4TM CARDIAC STIMULATOR, manufactured by Ep Medsystems. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Special 510(k) pathway after a 24-day FDA review.

K092913 · Ep Medsystems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
24d
Days
Class 2
Risk

K092913 is an FDA 510(k) clearance for the EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04. Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by Ep Medsystems (West Berlin, US). The FDA issued a Cleared decision on October 16, 2009 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1750 - 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 - K092913

510(k) Number K092913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2009
Decision Date October 16, 2009
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

JOQ Device Classification - Class 2, Special Controls

Product Code JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1750
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 - JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)

All 17
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K092913.
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K041442 · Ep Medsystems · Sep 2004
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K040207 · Ep Medsystems · Feb 2004
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K011826 · Micropace Pty, Ltd. · Jan 2002
K092913 · EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
Download PDF FDA Summary Ep Medsystems