Neos M Implantable Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Neos M

510(k) Number

K841636 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Pulse Generator

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  FDA 510(k) K821073 Active Cleared 7 May 1982

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• What is the Neos M used for in clinical practice and how does it work?

  The Neos M is an implantable pacemaker pulse-generator designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm. It is specifically intended for patients with bradycardia or conduction disorders, ensuring consistent heart contractions to support proper cardiac function.

• Is the Neos M meant for single-use or can it be reused after implantation?

  The Neos M is supplied sterile and intended for single-use only. It is not designed for reuse, and proper sterile handling is required to maintain its integrity before implantation.

• How should the Neos M be stored before use, and what precautions should be taken?

  The Neos M must be stored in its original packaging until use. Since it is not MRI-safe, it should also be kept away from magnetic fields or MRI equipment to prevent potential damage or interference with its function.

• What regulatory pathway does the Neos M follow, and what does this mean for clinicians?

  The Neos M is regulated under FDA 510(k) clearance (K841636) and classified as a Class III medical device, indicating it undergoes rigorous review for safety and effectiveness. Clinicians can rely on its compliance with cardiovascular device standards (870.3610) and its substantial equivalence determination, ensuring it meets established performance criteria for pacemaker pulse-generators.