Cleared Special

K022939 - OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES

K022939 is an FDA 510(k) clearance for OSCOR PACE 101/101H AND ACCESSORIES, manufactured by Osypka Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Special 510(k) pathway after a 29-day FDA review.

K022939 · Osypka Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K022939

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DTE Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K022939.
ERA 3000 PACING SYSTEM ANALYZER
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PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
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OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
K020896 · Osypka Medical, Inc. · Jun 2002
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K011980 · Pace Medical · Sep 2001
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
K002204 · Pace Medical · Oct 2000
K022939 · OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
Download PDF FDA Summary Osypka Medical, Inc.