Cleared Special

K041442 - EP-4 CLINICAL STIMUTATOR

K041442 is an FDA 510(k) clearance for EP-4 CLINICAL STIMUTATOR, 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 105-day FDA review.

K041442 · Ep Medsystems · Cardiovascular device
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Sep 2004
Decision
105d
Days
Class 2
Risk

K041442 is an FDA 510(k) clearance for the EP-4 CLINICAL STIMUTATOR. 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 September 14, 2004 after a review of 105 days - within the typical 510(k) review window.

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. 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 devices

FDA 510(k) Submission Details - K041442

510(k) Number K041442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2004
Decision Date September 14, 2004
Days to Decision 105 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 8
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K041442.
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K844815 · Cordis Corp. · Jun 1985
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