KALOS-03 Bipolar

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822907 ↗

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

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  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 primary purpose of the KALOS-03 Bipolar pacemaker, and how does it function in the body?

  The KALOS-03 Bipolar is designed as an implantable pacemaker pulse-generator to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is intended for patients with abnormal heartbeats, ensuring proper pacing to maintain a steady heartbeat when the heart’s natural conduction system is compromised.

• Is the KALOS-03 Bipolar intended for reuse, or is it meant to be implanted once and discarded?

  The device is explicitly intended for single-use implantation, meaning it is not designed for removal and reuse. After implantation, it remains in the patient’s body as a permanent solution for cardiac rhythm regulation.

• How is the KALOS-03 Bipolar supplied, and what precautions should be taken during handling?

  The device is supplied sterile and must be handled in a controlled clinical setting by trained medical professionals. Since it is implanted directly into the body, sterile techniques are critical to prevent infection or contamination during the procedure.

• What regulatory pathway does the KALOS-03 Bipolar follow, and how does it compare to other pacemakers?

  The KALOS-03 Bipolar is regulated under the FDA 510(k) clearance process (K822907) as a Class III device, classified as substantially equivalent to a predicate. This pathway confirms its safety and effectiveness for life-sustaining cardiovascular applications, aligning with standards under 21 CFR 870.3610 and categorized under product code DXY.

• Are there multiple models or sizes available for the KALOS-03 Bipolar, or is it a single standardized unit?

  The provided data does not specify multiple models or sizes for the KALOS-03 Bipolar, implying it is likely a single standardized unit designed for general use in pacemaker implantation. For precise sizing or model variations, consult the manufacturer’s technical documentation or a representative.