Cleared Traditional

K002204 - PACEMAKER EXTENSION CABLE MODELS 4265

K002204 is the FDA 510(k) clearance for PACEMAKER EXTENSION CABLE MODELS 4265 by Pace Medical. It is a Class 2 Cardiovascular device (product code DTE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002204 · Pace Medical · Cardiovascular device
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Oct 2000
Decision
90d
Days
Class 2
Risk

K002204 is an FDA 510(k) clearance for the PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 90 days - within the typical 510(k) review window.

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.

View all Pace Medical devices

Submission Details

510(k) Number K002204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2000
Decision Date October 18, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 26
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K002204.
Medtronic Model 5392 External Pulse Generator (EPG)
K150246 · Medtronic, Inc. · Feb 2015
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · Medtronic, Inc. · Oct 2013
ERA 3000 PACING SYSTEM ANALYZER
K042708 · Biotronik, Inc. · Oct 2004
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474 · Medtronic Vascular · Jul 1997
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K964190 · Biotronik, Inc. · Jul 1997
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991