Cleared Traditional

K001180 - TEMPORARY PACEMAKER EXTENSION CABLE

K001180 is the FDA 510(k) clearance for TEMPORARY PACEMAKER EXTENSION CABLE by Pace Medical. It is a Class 2 Cardiovascular device (product code DTE) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K001180 · Pace Medical · Cardiovascular device
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Jun 2000
Decision
77d
Days
Class 2
Risk

K001180 is an FDA 510(k) clearance for the TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PAC.... 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 June 27, 2000 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pace Medical devices

Submission Details

510(k) Number K001180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2000
Decision Date June 27, 2000
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 K001180.
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