Cleared Special

K022939 - OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES (FDA 510(k) Clearance)

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

K022939 · Osypka Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2002
Decision
29d
Days
Class 2
Risk

K022939 is an FDA 510(k) clearance for the OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORI.... 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 October 3, 2002 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Osypka Medical, Inc. devices

Submission Details

510(k) Number K022939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2002
Decision Date October 03, 2002
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K022939.
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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