Cleared Special

K040207 - EP-4 CLINICAL STIMULATOR

K040207 is an FDA 510(k) clearance for EP-4 CLINICAL 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 28-day FDA review.

K040207 · Ep Medsystems · Cardiovascular device
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Feb 2004
Decision
28d
Days
Class 2
Risk

K040207 is an FDA 510(k) clearance for the EP-4 CLINICAL STIMULATOR. 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 February 27, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1750 - 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 - K040207

510(k) Number K040207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2004
Decision Date February 27, 2004
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 K040207.
STIMLAB
K072200 · Micropace Pty, Ltd. · Oct 2007
Z6 STIMULATOR
K070743 · St Cardio Technologies, LLC · Jul 2007
EP-4 CLINICAL STIMUTATOR
K041442 · Ep Medsystems · Sep 2004
EPS320 CARDIAC STIMULATOR
K011826 · Micropace Pty, Ltd. · Jan 2002
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
K991293 · Fischer Medical Technologies, Inc. · May 2000
PACE-1A CARDIAC STIMULATOR
K963579 · Radionics, Inc. · Nov 1996
K040207 · EP-4 CLINICAL STIMULATOR
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