EPR-200 Programmer Model 010

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K800376 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

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 EPR-200 Programmer Model 010 in clinical settings?

  The EPR-200 Programmer Model 010 is designed to noninvasively adjust electrical parameters of implanted pacemakers, allowing clinicians to customize pacing therapy without requiring surgery. This enables real-time modifications to pacing settings, improving patient care in hospitals or cardiac care facilities.

• Is the EPR-200 Programmer Model 010 intended for single-use or reusable applications?

  The EPR-200 Programmer Model 010 is explicitly supplied as a reusable medical instrument, meaning it is built for repeated use in clinical environments like hospitals or cardiac care facilities.

• What regulatory pathway was used for FDA clearance of the EPR-200 Programmer Model 010?

  The EPR-200 Programmer Model 010 received FDA clearance through the 510(k) pathway, specifically under the traditional review process. It was classified as a Class III device by the FDA and was determined to be substantially equivalent to a predicate device, with clearance granted on April 21, 1980.

• Does the EPR-200 Programmer Model 010 have any specific sterility or MRI safety information provided?

  The available data for the EPR-200 Programmer Model 010 does not include any details regarding sterility requirements or MRI safety. Clinicians should verify compatibility with their facility’s MRI protocols and follow standard infection control practices for reusable devices.