Cleared Traditional

K935590 - EP MEDICAL

K935590 is an FDA 510(k) clearance for EP MEDICAL, manufactured by Ep Medical, Inc.. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K935590 · Ep Medical, Inc. · Cardiovascular device
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May 1994
Decision
168d
Days
Class 2
Risk

K935590 is an FDA 510(k) clearance for the EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR. Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by Ep Medical, Inc. (Budd Lake, US). The FDA issued a Cleared decision on May 5, 1994 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1750 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ep Medical, Inc. devices

FDA 510(k) Submission Details - K935590

510(k) Number K935590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date May 05, 1994
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 7
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K935590.
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