Rate Programmer Model 520

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780175 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Rate Programmer Model 520 and where is it typically used in a clinical setting?

  The Rate Programmer Model 520 is designed to program and adjust pacing parameters for implantable pacemakers, such as heart rate, timing intervals, and output settings. This ensures precise cardiac rhythm management for patients with bradycardia or other pacing-dependent conditions. It is intended for use in clinical settings like electrophysiology labs or cardiac care units by trained healthcare professionals.

• Is the Rate Programmer Model 520 a single-use or reusable device, and what maintenance does it require?

  The Rate Programmer Model 520 is supplied as a reusable medical instrument. Since it is not sterile and not intended for single-use, it requires proper calibration and regular maintenance to ensure accuracy, reliability, and compliance with regulatory standards for pacemaker programming equipment.

• How was the Rate Programmer Model 520 evaluated by the FDA, and what regulatory framework does it follow?

  The Rate Programmer Model 520 was evaluated through an FDA 510(k) clearance process, specifically under the Traditional clearance type. It was determined to be substantially equivalent to a predicate device and falls under FDA regulation number 870.3700 for pacemaker programming equipment. The device was reviewed by the Cardiovascular (CV) Advisory Committee.

• What types of pacing parameters can the Rate Programmer Model 520 adjust, and why is this important for patients?

  The Rate Programmer Model 520 allows adjustments to pacing parameters such as heart rate, timing intervals, and output settings. These adjustments are critical for managing patients with bradycardia or other pacing-dependent conditions, ensuring their pacemakers function optimally to maintain a stable and effective cardiac rhythm.