Neos-M Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844795 ↗

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

  Class III

  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 NEOS-M Pulse Generator and who would benefit from it?

  The NEOS-M Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, serving as an implantable pacemaker. 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-M Pulse Generator intended for single-use or can it be reused after implantation?

  The NEOS-M Pulse Generator is supplied sterile and intended for single-use implantation. While it may be reprogrammable or replaceable in certain clinical settings, it is not designed for reuse after initial implantation to maintain sterility and patient safety.

• How should the NEOS-M Pulse Generator be stored, and what precautions must be taken?

  The NEOS-M Pulse Generator must be stored and handled according to sterile medical device protocols to ensure proper functionality and patient safety. This includes maintaining its sterile packaging until the time of use and adhering to manufacturer guidelines for storage conditions.

• What regulatory pathway does the NEOS-M Pulse Generator follow, and what does this mean for its use?

  The NEOS-M Pulse Generator follows the FDA 510(k) clearance pathway, specifically with clearance number K844795, and is classified as a Class III medical device. This means it has undergone a review process to demonstrate substantial equivalence to a predicate device, ensuring it meets FDA standards for safety and effectiveness before being authorized for use in the United States.