Cleared Traditional

PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V (K002204) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

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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 64
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K002204.
Solo Pace Control
K241781 · Solo Pace, Inc. · Jan 2025
Lifetech Cardio Temporary Pacemaker
K232721 · Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. · Jan 2024
Medtronic Model 5392 External Pulse Generator (EPG)
K201011 · Medtronic, Inc. · May 2020
Medtronic Model 5392 External Pulse Generator (EPG)
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