Unilith Pulse Generator

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

510(k) Number

K791219 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

See all devices from Ela Medical, Inc. →

• What is the primary purpose of the Unilith Pulse Generator and how does it function in a patient’s heart?

  The Unilith Pulse Generator is designed to regulate heart rhythm in patients with bradycardia or cardiac conduction disorders by delivering controlled electrical impulses. It acts as the power source and control unit for pacing systems, ensuring consistent cardiac output through programmed stimulation to maintain proper heart function.

• Is the Unilith Pulse Generator intended for reuse or single-use, and what does this mean for clinical workflow?

  The Unilith Pulse Generator is supplied sterile and intended for single-use only. This means each device is meant to be implanted once in a patient and should not be reused, reducing infection risks and ensuring reliability in a controlled surgical setting.

• How is the Unilith Pulse Generator regulated by the FDA, and what does this imply for healthcare providers?

  The Unilith Pulse Generator is classified as a Class III medical device under FDA regulations and holds a 510(k) clearance (K791219). This classification indicates it is a high-risk device requiring strict compliance with FDA standards, and it must be implanted by qualified healthcare professionals in a clinical setting to ensure proper use and patient safety.

• What product codes and regulatory details are associated with the Unilith Pulse Generator?

  The Unilith Pulse Generator is regulated under FDA product code DXY and falls under the Cardiovascular medical specialty. It was cleared through a traditional 510(k) pathway with no third-party distribution involvement, and its regulatory file number is K791219. These details reflect its classification as an implantable pacemaker pulse-generator.