KALOS-03 Implantable Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Kalos-03

510(k) Number

K812218 ↗

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

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• What is the Kalos-03 used for in clinical practice, and how does it differ from other pacemakers?

  The Kalos-03 is an implantable pacemaker pulse-generator designed specifically to regulate heart rhythm by delivering electrical impulses when the heart’s natural contractions are too slow or irregular. It is intended for patients with bradycardia or conduction disorders requiring chronic pacing support, functioning either as a standalone device or as part of a larger pacing system. Unlike some pacemakers that may offer additional features like cardiac resynchronization or defibrillation, the Kalos-03 focuses solely on basic pacing functionality for bradycardia management.

• Is the Kalos-03 intended for single-use or can it be reused after implantation?

  The Kalos-03 is explicitly supplied as a single-use implantable device. It is intended for surgical implantation by qualified healthcare professionals and is not designed for reuse. This aligns with standard practices for implantable pulse-generators to ensure patient safety and sterility.

• What regulatory pathway was followed for the Kalos-03, and what does this mean for its use in clinical settings?

  The Kalos-03 was cleared through the FDA’s 510(k) pathway, specifically under the Traditional review process, and is classified as a Class III device under the DXY product code. This classification indicates it is a high-risk, life-sustaining device, meaning it undergoes rigorous evaluation to ensure safety and effectiveness. Clinically, this means it is subject to strict manufacturing, labeling, and post-market surveillance requirements to maintain its regulatory compliance.

• How is the Kalos-03 supplied, and what considerations should be made during storage or handling?

  The Kalos-03 is supplied as a sterile, single-use implantable device intended for surgical implantation in a sterile operating environment. While the regulatory data does not specify storage conditions beyond standard medical device handling, it is critical to follow manufacturer guidelines for temperature, humidity, and shelf life to preserve sterility and functionality. Always ensure the device is stored in its original packaging until ready for use.