Cleared Abbreviated

OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE (K020896) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K020896 · Osypka Medical, Inc. · Cardiovascular device
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Jun 2002
Decision
87d
Days
Class 2
Risk

K020896 is an FDA 510(k) clearance for the OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, .... Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Osypka Medical, Inc. (La Jolla, US). The FDA issued a Cleared decision on June 14, 2002 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Osypka Medical, Inc. devices

Submission Details

510(k) Number K020896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2002
Decision Date June 14, 2002
Days to Decision 87 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 - DTE Pulse-generator, Pacemaker, External

All 64
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K020896.
Solo Pace Control
K241781 · Solo Pace, Inc. · Jan 2025
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K232721 · Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. · Jan 2024
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K201011 · Medtronic, Inc. · May 2020
Medtronic Model 5392 External Pulse Generator (EPG)
K190825 · Medtronic, Inc. · Apr 2019
Lifetech Cardio Model 8301 Temporary Pacemaker
K182839 · Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. · Feb 2019
Medtronic Model 5392 External Pulse Generator (EPG)
K181973 · Medtronic, Inc. · Aug 2018