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Kalos 05 Pulse Generator

by Biotronik Cardiac Pacemakers

510(k) K896184

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896184 Date18 Jan 1990ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kalos 05 Pulse Generator is an implantable pacemaker pulse-generator designed to deliver electrical impulses to the heart for bradycardia therapy. It is classified as a Class III device under FDA regulations and is intended to restore a regular sinus rhythm and maintain an adequate heart rate in patients with slow heart rhythms.

This device is supplied as a single-use, implantable component and is regulated under FDA 510(k) clearance (K896184). It is intended for use in a clinical setting by trained healthcare professionals and must be implanted surgically. The device is not MRI-safe and requires proper storage and handling as specified in its instructions for use. Authorisation includes FDA clearance under the product code DXY and regulation number 870.3610.

Other devices from Biotronik Cardiac Pacemakers

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical purpose of the Kalos 05 Pulse Generator and how does it achieve this?

    The Kalos 05 Pulse Generator is designed to treat bradycardia, a condition where the heart beats too slowly, by delivering timed electrical impulses to restore a regular sinus rhythm and maintain an adequate heart rate. It functions as an implantable pacemaker, continuously monitoring the heart’s electrical activity and providing stimulation when the natural rhythm falls below safe thresholds.

  • Is the Kalos 05 Pulse Generator intended for single-use or can it be reused after implantation?

    The Kalos 05 Pulse Generator is explicitly supplied as a single-use device. Once implanted, it is not designed for removal or reuse, and its intended lifespan is for long-term, permanent use within the patient’s body.

  • What safety considerations should clinicians be aware of when handling or storing this device?

    The Kalos 05 Pulse Generator is not MRI-safe, meaning it should never be exposed to magnetic resonance imaging. Proper storage and handling must follow the manufacturer’s instructions to preserve sterility and functionality, as it is intended for sterile surgical implantation by trained healthcare professionals.

  • How is the regulatory status of this device determined, and what does that mean for its use?

    The Kalos 05 Pulse Generator is classified as a Class III medical device under FDA regulations and has received 510(k) clearance (K896184) through a traditional review process by the Cardiovascular (CV) Advisory Committee. This clearance confirms it meets FDA standards for safety and effectiveness as an implantable pacemaker pulse-generator, ensuring it can be legally implanted in clinical settings by qualified professionals.