Cleared Traditional

K900553 - CONSTANT CURRENT STIMULATOR MODEL 022101

K900553 is an FDA 510(k) clearance for CONSTANT CURRENT STIMULATOR MODEL 022101, manufactured by Ep Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K900553 · Ep Technologies, Inc. · Cardiovascular device
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Mar 1990
Decision
35d
Days
Class 2
Risk

K900553 is an FDA 510(k) clearance for the CONSTANT CURRENT STIMULATOR MODEL 022101. Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by Ep Technologies, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 13, 1990 after a review of 35 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ep Technologies, Inc. devices

FDA 510(k) Submission Details - K900553

510(k) Number K900553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1990
Decision Date March 13, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
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 9
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K900553.
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