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Medtronic External Pulse Generator EPG

by Medtronic, Inc.

510(k) K132924

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132924 Date31 Oct 2013ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1356-2015 FDA Class II initiated 17 Mar 2015

    Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.

Timeline

2 dated events

  1. Cleared FDA 510(k) K132924
  2. Recall initiated FDA recalls Z-1356-2015

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DTE
Device class
Class II
Regulation
21 CFR Part 870.3600
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medtronic External Pulse Generator is a battery-powered, dual-chamber temporary pacemaker used to provide antibradycardia pacing therapy. As an external pacemaker pulse generator, it functions as a prescription device that utilizes electronic circuits to produce periodic electrical pulses to stimulate the heart. The device connects to cardiac pacing lead systems to deliver either synchronous demand or asynchronous pacing as a temporary substitute for the heart's intrinsic pacing.

This device is intended for use in clinical environments by trained personnel and features an optional disposable protective cover. It has received FDA 510(k) clearance under the cardiovascular medical specialty. Users should refer to the specific model documentation for operational details and storage requirements.

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