Cleared Traditional

K933069 - MODEL EP-2 CLINICAL STIMULATOR

K933069 is an FDA 510(k) clearance for MODEL EP-2 CLINICAL STIMULATOR, manufactured by Ep Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTA cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K933069 · Ep Medical, Inc. · Cardiovascular device
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Oct 1993
Decision
121d
Days
Class 2
Risk

K933069 is an FDA 510(k) clearance for the MODEL EP-2 CLINICAL STIMULATOR. Classified as Tester, Pacemaker Electrode Function (product code DTA), Class II - Special Controls.

Submitted by Ep Medical, Inc. (Budd Lake, US). The FDA issued a Cleared decision on October 21, 1993 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3720 - 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 - K933069

510(k) Number K933069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date October 21, 1993
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTA Device Classification - Class 2, Special Controls

Product Code DTA Tester, Pacemaker Electrode Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3720
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 - DTA Tester, Pacemaker Electrode Function

Devices cleared under the same product code (DTA) and FDA review panel - the closest regulatory comparables to K933069.
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