NEDS-01 & EPR-500 Implantable Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Neds-01 & Epr-500

510(k) Number

K830862 ↗

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

See all devices from Biotronik Sales, Inc. →

• What types of heart conditions is the NEDS-01 & EPR-500 pacemaker designed to treat, and how does it work?

  The NEDS-01 & EPR-500 is specifically designed for patients with bradycardia or other conduction disorders that require chronic cardiac pacing. It functions as an implantable pacemaker pulse-generator, delivering controlled electrical impulses to the heart when natural contractions are insufficient, thereby regulating heart rhythm.

• Is the NEDS-01 & EPR-500 intended for single-use or reusable applications, and what does this mean for patients?

  The NEDS-01 & EPR-500 is supplied as a single-use, implantable system, meaning it is intended for permanent implantation in a patient and is not designed for removal or reuse. This ensures sterile, one-time use within the body, reducing infection risks.

• How was the regulatory pathway for this device determined, and what does the ‘Traditional review pathway’ imply for its approval?

  The NEDS-01 & EPR-500 was cleared under the FDA 510(k) pathway with a Traditional review, meaning its safety and effectiveness were evaluated by the FDA to determine if it is substantially equivalent to a legally marketed predicate device. The Cardiovascular (CV) advisory committee provided input during this process, ensuring compliance with cardiovascular device standards.

• What product code and regulatory classification does this device fall under, and why does this matter?

  The NEDS-01 & EPR-500 is classified under product code DXY and regulated under FDA regulation number 870.3610, which governs implantable pacemaker pulse-generators. This classification ensures it meets strict quality, performance, and safety standards for Class III devices, which require rigorous pre-market approval due to their critical role in patient care.

• How long has this device been available, and what does the early clearance date (1983) indicate about its historical significance?

  The NEDS-01 & EPR-500 received its FDA 510(k) clearance on May 25, 1983, making it one of the earlier pacemaker systems to undergo modern regulatory review in the U.S. This early clearance reflects its foundational role in establishing chronic cardiac pacing as a standard treatment for bradycardia and conduction disorders, with ongoing compliance updates through subsequent registrations.