Cleared Traditional

K162054 - Medtronic Temporary External Pacemaker 53401 (FDA 510(k) Clearance)

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

K162054 · Medtronic, Inc. · Cardiovascular device
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Oct 2016
Decision
85d
Days
Class 2
Risk

K162054 is an FDA 510(k) clearance for the Medtronic Temporary External Pacemaker 53401. 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 18, 2016 after a review of 85 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 K162054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date October 18, 2016
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K162054.
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