Device (255A Programmer III +2 more) - Software Revi. 4004

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K882429 ↗

FDA Product Code

KRG

Models / Variants

255A Programmer Iii

W

Software Revi. 4004

Device Class

Class III

Regulation

21 CFR Part 870.3700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vicor Pacer Model 410A

  Class III

  FDA 510(k) K880432 Active Cleared 22 Feb 1988

• Vicor Model 410A Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K873202 Active Cleared 15 Oct 1987

• Modified Multicor and Omni-Stanicor Pacemakers

  Class III

  FDA 510(k) K873158 Active Cleared 7 Jan 1988

• Modified Ancor Hi-Flex Unipolar Active Fix Lead

  Class III

  FDA 510(k) K885240 Active Cleared 10 Feb 1989

• Multicor Pacemakers

  Class III

  FDA 510(k) K880898 Active Cleared 6 May 1988

• What is the primary purpose of the Model 255A Programmer III and how does it differ from other pacemaker programmers?

  The Model 255A Programmer III is designed specifically to control and adjust the operating parameters—such as pacing rate, output, and timing—of implanted cardiac pacemakers. Unlike some other programmers, it is tailored for precise programming of pacing functions in clinical settings like electrophysiology labs or hospital ECG departments, ensuring optimized patient therapy. Its software revision (Rev. 4004) suggests it may include updated features or improvements over earlier models, though the exact differences would require consulting the manufacturer’s documentation.

• Is the Model 255A Programmer III a single-use or reusable device, and what maintenance is required?

  The Model 255A Programmer III is a reusable electronic unit, meaning it is not intended for single-use disposal. While it does not require sterility (as it is not used in direct patient contact), it must be maintained according to the manufacturer’s guidelines to ensure accurate and reliable operation. Proper calibration, software updates, and routine servicing are critical to its performance.

• What regulatory pathway does the Model 255A Programmer III follow, and what does this mean for its use?

  The Model 255A Programmer III follows the FDA’s 510(k) clearance pathway, classified as a Class III device under regulation number 870.3700. This classification indicates it is subject to stringent oversight due to its role in controlling life-sustaining cardiac devices. The device holds a traditional 510(k) clearance (K882429) and was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee, ensuring it meets safety and effectiveness standards for use in clinical settings by trained healthcare professionals.

• Who is authorized to use the Model 255A Programmer III, and where is it typically deployed?

  The Model 255A Programmer III is intended for use by trained healthcare professionals, specifically in specialized environments like cardiac electrophysiology labs or hospital electrocardiography departments. Its design and programming capabilities are tailored for clinical applications where precise adjustments to implanted pacemakers are required, ensuring optimal patient therapy under medical supervision.