NEOS VS-1 Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K860921 ↗

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

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  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 NEOS VS-1 Pulse Generator used for in clinical practice?

  The NEOS VS-1 Pulse Generator is an implantable pacemaker designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients who require cardiac pacing support, such as those with bradycardia or other conditions causing an abnormally slow heart rate.

• Is the NEOS VS-1 Pulse Generator meant for single-use or can it be reused?

  The NEOS VS-1 Pulse Generator is supplied sterile and explicitly intended for single-use implantation only. It must be implanted by qualified medical professionals in a clinical setting and is not designed for reuse.

• What should I know about MRI compatibility with the NEOS VS-1 Pulse Generator?

  The NEOS VS-1 Pulse Generator is labeled as MRI-unspecified, meaning its safety and functionality during MRI procedures have not been explicitly defined. Manufacturer guidelines must be followed strictly to ensure patient safety, as improper handling could risk device malfunction or harm.

• How was the NEOS VS-1 Pulse Generator reviewed and approved by the FDA?

  The NEOS VS-1 Pulse Generator received FDA 510(k) clearance through a traditional review process by the Cardiovascular (CV) Advisory Committee. It was determined to be substantially equivalent to a legally marketed predicate device, falling under product code DXY and classified as a Class III medical device under regulation 870.3610.