KALOS-04 Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844841 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Biotronik DN Unipolar PE-60/4-DN Electrode

  Class III

  FDA 510(k) K833098 Active Cleared 19 Oct 1983

• Biotronik D2K Unipolar PE-60/4

  Class III

  FDA 510(k) K833104 Active Cleared 19 Oct 1983

• Leptos Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K841635 Active Cleared 3 Aug 1984

• EDP-20 Pacemaker

  Class III

  FDA 510(k) K860036 Active Cleared 12 Jan 1987

• Pulse Generator

  Class III

  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K863480 Active Cleared 23 Sep 1986

See all devices from Biotronik Sales, Inc. →

• What is the primary clinical purpose of the KALOS-04 Pulse Generator and how does it function in patients?

  The KALOS-04 Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients with bradycardia or conduction disorders. It acts as an implantable pacemaker, ensuring proper pacing to maintain a normal heart rate when the heart’s natural electrical system is impaired.

• Is the KALOS-04 Pulse Generator intended for single-use or can it be reused after implantation?

  The KALOS-04 Pulse Generator is explicitly described as a reusable medical device, meaning it is intended to remain implanted in the patient long-term after surgical placement. It is not designed for single-use or removal after a single procedure.

• How is the KALOS-04 Pulse Generator supplied, and what does 'sterile' mean in this context?

  The device is supplied sterile, which means it is packaged and prepared to be free from living microorganisms that could cause infection. This ensures safe surgical implantation without introducing contaminants during the procedure.

• What regulatory pathway was followed for the FDA clearance of the KALOS-04 Pulse Generator, and what does this imply for its use?

  The KALOS-04 Pulse Generator received FDA clearance through a 510(k) submission, classified as substantially equivalent (SESE) under the Traditional review pathway. This implies the device meets FDA standards for safety and effectiveness as a Class III cardiovascular implantable device, adhering to strict regulatory requirements for cardiac pacing technology.