Cleared Traditional

K001180 - TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

K001180 is an FDA 510(k) clearance for TEMPORARY PACEMAKER EXTENSION CABLE, manufactured by Pace Medical. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K001180

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
Combination Product No
PCCP Authorized No
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.

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 54
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