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Medtronic Temporary External Pacemaker 53401

by Medtronic, Inc.

510(k) K162054

Medtronic Temporary External Pacemaker 53401 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K162054 on 18 Oct 2016, active as of 9 Oct 2026. One FDA recall is linked to it.

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 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162054 Date18 Oct 2016ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-2317-2018 FDA Class II initiated 6 Jun 2018

    A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR).

Timeline

2 dated events

  1. Cleared FDA 510(k) K162054
  2. Recall initiated FDA recalls Z-2317-2018

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  • Withdrawn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

cited in the FDA summary

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

Cites

Cited by

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

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