NEOS Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844812 ↗

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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  FDA 510(k) K821073 Active Cleared 7 May 1982

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• What is the NEOS Pulse Generator used for in clinical practice?

  The NEOS Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients with bradycardia or conduction disorders. It ensures consistent and reliable cardiac output through programmable pacing parameters, helping maintain proper heart function in those requiring artificial pacing.

• Is the NEOS Pulse Generator intended for single-use or reusable implantation?

  The NEOS Pulse Generator is explicitly intended for single-use implantation after being supplied sterile. This aligns with standard practices for implantable devices to minimize infection risks and ensure patient safety.

• How should the NEOS Pulse Generator be stored and handled?

  Since the NEOS Pulse Generator is supplied sterile, it must be stored and handled according to sterile medical device protocols to preserve its integrity before implantation. Improper storage could compromise sterility and patient safety.

• Are there any MRI safety restrictions for patients with the NEOS Pulse Generator implanted?

  The provided data does not specify any MRI safety restrictions for the NEOS Pulse Generator. However, as with all implantable cardiac devices, MRI use should always be evaluated on a case-by-case basis by a healthcare professional to assess potential risks.

• What regulatory pathway was followed for the NEOS Pulse Generator’s FDA clearance?

  The NEOS Pulse Generator received FDA 510(k) clearance (K844812) under the traditional review pathway, classified as substantially equivalent (SESE) to a predicate device. It falls under product code DXY and is regulated under 21 CFR 870.3610, with a review by the Cardiovascular (CV) Advisory Committee.