Cleared Traditional

K132924 - MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)

K132924 is the FDA 510(k) clearance for MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DTE) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K132924 · Medtronic, Inc. · Cardiovascular device
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Oct 2013
Decision
43d
Days
Class 2
Risk

K132924 is an FDA 510(k) clearance for the MEDTRONIC EXTERNAL PULSE GENERATOR (EPG). Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 43 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 Medtronic, Inc. devices

Submission Details

510(k) Number K132924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date October 31, 2013
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
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 23
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K132924.
Medtronic Temporary External Pacemaker 53401
K162054 · Medtronic, Inc. · Oct 2016
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Medtronic Model 5392 External Pulse Generator (EPG)
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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