Cleared Traditional

EPS320 CARDIAC STIMULATOR (K011826) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011826 · Micropace Pty, Ltd. · Cardiovascular device
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Jan 2002
Decision
227d
Days
Class 2
Risk

K011826 is an FDA 510(k) clearance for the EPS320 CARDIAC STIMULATOR. Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by Micropace Pty, Ltd. (Campsie, N.S.W., AU). The FDA issued a Cleared decision on January 24, 2002 after a review of 227 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 Micropace Pty, Ltd. devices

Submission Details

510(k) Number K011826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2001
Decision Date January 24, 2002
Days to Decision 227 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 125d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K011826.
Bloom2 Programmable Electrophysiology Stimulator
K173439 · Fischer Medical · Mar 2018
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
K861368 · Medtronic Vascular · Aug 1986
CORDIS ELECTROPHYSIOLOGY STIMULATOR
K844815 · Cordis Corp. · Jun 1985
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
K851091 · Medtronic Vascular · Apr 1985
PROGRAMMABLE STIMULATOR 5326
K843718 · Medtronic Vascular · Sep 1984
PROGRAMMABLE STIMULATOR 2352
K833421 · Medtronic Vascular · Jan 1984