Cleared Special

K033130 - PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR

K033130 is an FDA 510(k) clearance for PACE 101/PACE 101H, 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 31-day FDA review.

K033130 · Osypka Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
31d
Days
Class 2
Risk

K033130 is an FDA 510(k) clearance for the PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR. 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 31, 2003 after a review of 31 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 - K033130

510(k) Number K033130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date October 31, 2003
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
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 K033130.
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · Medtronic, Inc. · Oct 2013
PSA SERIES
K123916 · Osypka Medical, Inc. · Apr 2013
ERA 3000 PACING SYSTEM ANALYZER
K042708 · Biotronik, Inc. · Oct 2004
GALIX PACESTAR
K023080 · Galix Biomedical Instrumentation, Inc. · Jun 2003
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
K022939 · Osypka Medical, Inc. · Oct 2002
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
K033130 · PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
Download PDF FDA Summary Osypka Medical, Inc.