Cleared Special

K150246 - Medtronic Model 5392 External Pulse Generator (EPG) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K150246 · Medtronic, Inc. · Cardiovascular device
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Feb 2015
Decision
16d
Days
Class 2
Risk

K150246 is an FDA 510(k) clearance for the Medtronic Model 5392 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 February 18, 2015 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K150246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date February 18, 2015
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K150246.
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