TP 1 Pacemaker Programmer

No FDA recalls on record, checked 22 Oct 2026.

Full name

Tp 1

510(k) Number

K844483 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacemakers, Vitatron's

  Class III

  FDA 510(k) K760669 Active Cleared 12 Nov 1976

• Cardiac Pacemaker P4000 Ser. & P1000

  Class III

  FDA 510(k) K791920 Active Cleared 29 Nov 1979

• Cardiac Pacemaker C4000, C1000 Ser.

  Class III

  FDA 510(k) K791921 Active Cleared 26 Oct 1979

• External Test Pulse Generator

  Class II

  FDA 510(k) K780717 Active Cleared 30 Jun 1978

• Electrode Pacemaker, Perm & Temp

  Class III

  FDA 510(k) K840668 Active Cleared 24 Sep 1984

• Endocardial Electrode

  Class III

  FDA 510(k) K810928 Active Cleared 2 Jul 1981

See all devices from Vitatron Medical BV →

• What types of pacemakers is the TP 1 compatible with, and how do I verify compatibility before use?

  The TP 1 is designed to interface with specific pacemaker models, which are identified by their registration numbers. Compatibility is determined by the listed registration numbers provided in the device specifications: 3011120183, 2017865, 3005334138, and others. Always check the pacemaker’s registration number against this list before use to ensure proper programming, monitoring, and adjustments.

• Is the TP 1 a single-use or reusable device, and what cleaning and sterilization procedures should be followed?

  The TP 1 is a reusable medical instrument intended for use in clinical settings like hospitals and electrophysiology labs. Since it is not sterile upon delivery, it must be thoroughly cleaned and sterilized between uses to maintain safety and functionality. Follow manufacturer guidelines for cleaning and sterilization to ensure proper hygiene.

• What is the regulatory pathway for the TP 1, and which advisory committee was involved in its review?

  The TP 1 received FDA clearance through a 510(k) submission, classified under the Cardiovascular advisory committee (CV). The clearance was granted under a traditional review process, meaning it underwent a detailed evaluation by the FDA to determine substantial equivalence to a predicate device. This device is regulated under FDA regulation 870.3700.

• Can the TP 1 be used with pacemakers in an MRI environment, and what safety precautions should be taken?

  The TP 1’s compatibility with MRI environments is not specified in the available data. Since MRI safety can vary depending on the specific pacemaker model and the TP 1’s design, it is critical to consult the pacemaker manufacturer’s guidelines and ensure the device is not exposed to MRI fields unless explicitly approved for such use. Always follow strict safety protocols to avoid risks to patients.

• How do I determine if the TP 1 is suitable for my clinical setting, such as a hospital or electrophysiology lab?

  The TP 1 is explicitly designed for use in clinical settings like hospitals and electrophysiology labs, where it can be used to program, monitor, and adjust pacemaker settings. Its reusable nature and diagnostic/therapeutic functions make it suitable for environments where multiple patients require pacemaker management. Ensure your facility has the necessary infrastructure for cleaning, sterilization, and proper handling of the device.