Cleared Traditional

K023080 - GALIX PACESTAR

K023080 is an FDA 510(k) clearance for GALIX PACESTAR, manufactured by Galix Biomedical Instrumentation, Inc.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K023080 · Galix Biomedical Instrumentation, Inc. · Cardiovascular device
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Jun 2003
Decision
267d
Days
Class 2
Risk

K023080 is an FDA 510(k) clearance for the GALIX PACESTAR. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Galix Biomedical Instrumentation, Inc. (Miami Beach, US). The FDA issued a Cleared decision on June 11, 2003 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - 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.

FDA 510(k) Submission Details - K023080

510(k) Number K023080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2002
Decision Date June 11, 2003
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K023080.
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K033130 · Osypka Medical, Inc. · Oct 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
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K011980 · Pace Medical · Sep 2001
K023080 · GALIX PACESTAR
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