Pacemaker Programmer #2032

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831859 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

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 is the primary purpose of the Pacemaker Programmer #2032 and where is it typically used?

  The Pacemaker Programmer #2032 is designed to program and adjust settings on implanted pacemaker pulse generators, allowing clinicians to configure critical parameters like heart rate, output voltage, and timing intervals. It is intended for use in clinical settings such as cardiac electrophysiology labs or hospital electrophysiology units by trained healthcare professionals to optimize cardiac rhythm management for patients with bradycardia or other pacing-dependent conditions.

• Is the Pacemaker Programmer #2032 a single-use or reusable device, and what maintenance is required?

  The Pacemaker Programmer #2032 is supplied as a reusable medical instrument. Since it is intended for repeated use, it requires proper calibration and maintenance to ensure accurate programming and patient safety, as outlined in its design and regulatory compliance.

• What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

  The Pacemaker Programmer #2032 received FDA clearance through a Traditional 510(k) review process, classified under product code DXY for Implantable Pacemaker Pulse-Generators. It was determined to be substantially equivalent to a predicate device and received clearance on October 27, 1983, with the 510(k) number K831859.

• Which medical specialty is primarily responsible for using this device, and what type of clinical environment is it intended for?

  The Pacemaker Programmer #2032 is primarily intended for use by professionals in the cardiovascular specialty, particularly in clinical environments such as cardiac electrophysiology labs or hospital electrophysiology units. These settings provide the necessary infrastructure and expertise to safely program and monitor implanted pacemaker pulse generators.