Pulse Generator KALOS-04

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841950 ↗

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 clinical conditions is the Pulse Generator Kalos-04 designed to address, and how does it work?

  The Pulse Generator Kalos-04 is specifically designed to regulate cardiac rhythm for patients with bradycardia or conduction disorders. It achieves this by delivering controlled electrical impulses to the heart, ensuring consistent and reliable cardiac function. This device is intended for implantation in patients who require pacing support to maintain proper heart rhythm.

• Is the Pulse Generator Kalos-04 intended for single-use or reusable implantation, and how should it be handled?

  The Pulse Generator Kalos-04 is supplied sterile and intended for single-use implantation only. Due to its sterile packaging, it must be handled following strict sterile medical device protocols to prevent contamination before and during use. Reuse is not recommended or supported by the manufacturer.

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

  The Pulse Generator Kalos-04 received FDA clearance through the Traditional 510(k) pathway under the product code DXY and regulation 870.3610. This classification aligns with its designation as a high-risk, life-sustaining cardiovascular device, specifically an Implantable Pacemaker Pulse-Generator.

• Does the device have any known compatibility with MRI procedures, and what storage requirements apply?

  The device data does not specify any MRI safety data, meaning its compatibility with MRI procedures is not confirmed or recommended. For storage, the Pulse Generator Kalos-04 must be kept in accordance with sterile medical device protocols to maintain its integrity and sterility until implantation.

• What advisory committee reviewed this device submission, and how does that relate to its intended use?

  The submission for the Pulse Generator Kalos-04 was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee, which evaluates devices intended for cardiovascular applications. This committee’s involvement reflects the device’s classification as a high-risk, life-sustaining pacemaker, ensuring its safety and effectiveness for patients requiring pacing support due to bradycardia or conduction disorders.