Cleared Traditional

K011826 - EPS320 CARDIAC STIMULATOR

K011826 is an FDA 510(k) clearance for EPS320 CARDIAC STIMULATOR, manufactured by Micropace Pty, Ltd.. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Traditional 510(k) pathway after a 227-day FDA review.

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

FDA 510(k) Submission Details - K011826

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
Combination Product No
PCCP Authorized No
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.

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 13
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K011826.
STIMLAB
K072200 · Micropace Pty, Ltd. · Oct 2007
Z6 STIMULATOR
K070743 · St Cardio Technologies, LLC · Jul 2007
EP-4 CLINICAL STIMUTATOR
K041442 · Ep Medsystems · Sep 2004
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
K991293 · Fischer Medical Technologies, Inc. · May 2000
PACE-1A CARDIAC STIMULATOR
K963579 · Radionics, Inc. · Nov 1996
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
K861368 · Medtronic Vascular · Aug 1986