Pulse Generator, Pacemaker #532

No FDA recalls on record, checked 22 Oct 2026.

Full name

Generator, Pulse, Pacemaker #532

510(k) Number

K831860 ↗

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 clinical purpose of the Pulse Generator, Pacemaker #532, and how does it address patient needs?

  The Pulse Generator, Pacemaker #532 is designed to regulate abnormal heart rhythms by delivering controlled electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper cardiac function through consistent pacing. This helps maintain a stable heart rhythm, reducing symptoms like fatigue, dizziness, or fainting.

• Is this device intended for single-use or can it be reused after implantation?

  The Pulse Generator, Pacemaker #532 is supplied sterile and explicitly labeled for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, functionality, or patient safety. Adherence to single-use guidelines is critical to maintaining regulatory compliance and device efficacy.

• How should this pacemaker be stored to ensure it remains functional and safe for use?

  Since the Pulse Generator, Pacemaker #532 is sterile and intended for surgical implantation, it must be stored according to sterile medical device protocols. This includes keeping it in its original packaging, protected from moisture, extreme temperatures, and physical damage. Proper storage ensures the device remains uncontaminated and ready for use when needed.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Pulse Generator, Pacemaker #532 received FDA 510(k) clearance (K831860) under the traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared pacemaker, ensuring it meets safety and effectiveness standards for implantation in patients with bradycardia or conduction disorders.