Unifocal 1 Unipolar Demand R Wave

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K791955 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Apc Implantabel Pacing Lead, Model 3264

  Class III

  FDA 510(k) K810399 Active Cleared 15 May 1981

• APC Implantable Pacing Lead, Tined #3262

  Class III

  FDA 510(k) K810396 Active Cleared 15 May 1981

• APC Implantable Pacing Lead-Flange #3260

  Class III

  FDA 510(k) K810397 Active Cleared 15 May 1981

• External Pulse Generator EV4542

  Class II

  FDA 510(k) K821791 Active Cleared 6 Jul 1982

• Unifocal 2-UNIPOLAR & Bipolar

  Class III

  FDA 510(k) K792199 Active Cleared 27 Nov 1979

• APC Implantable Pacing Lead, Model 3266

  Class III

  FDA 510(k) K810398 Active Cleared 15 May 1981

See all devices from American Pacemaker Corp. →

• What is the primary purpose of the Unifocal 1 Unipolar Demand R Wave pacemaker, and how does it differ from other pacing modes?

  The Unifocal 1 Unipolar Demand R Wave pacemaker is designed to provide cardiac pacing for patients with bradycardia or conduction disorders by operating in a unipolar demand mode. Unlike fixed-rate pacemakers, it senses the patient’s intrinsic R-wave and delivers pacing impulses only when the heart’s natural rhythm falls below a preset threshold, ensuring synchronized contractions and efficient cardiac function.

• Is this device intended for reuse, or is it meant for single-use implantation only?

  This device is explicitly supplied sterile and intended for single-use implantation. It requires proper surgical placement by a trained clinician, and no reusable components are noted in the specifications.

• What regulatory pathway was followed for FDA clearance of this device, and what product code does it fall under?

  The Unifocal 1 Unipolar Demand R Wave pacemaker received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent (SESE). It is regulated under the product code DXY and falls under the Cardiovascular medical specialty, with no noted MRI safety restrictions.

• How long has this device been cleared by the FDA, and what was the original submission date?

  The device was originally submitted to the FDA on October 1, 1979, and received clearance on November 27, 1979, making it one of the earliest pacemaker models cleared under the 510(k) pathway. Its clearance (K791955) remains active for use in implantable cardiac pacing.

• What type of surgical expertise is required for implantation of this device?

  This device is designed for implantable use within the cardiovascular setting and requires proper surgical placement by a trained clinician, likely a cardiologist or cardiac surgeon, due to its invasive nature and specialized pacing function.