Pacemaker Programmer 2030

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

510(k) Number

K820230 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What types of implanted pacemakers is the Pacemaker Programmer 2030 compatible with, and how do I verify compatibility for my specific model?

  The Pacemaker Programmer 2030 is designed to work with a wide range of implanted pacemaker models, as indicated by its compatibility with multiple OpenFDA registration numbers (e.g., 3011120183, 2017865, etc.). To verify compatibility for your specific pacemaker, check if its registration number appears in the listed OpenFDA registration_number field. This ensures the programmer can interface, program, and monitor your device’s pacing parameters. Always confirm with your manufacturer or a technical specialist if unsure.

• Is the Pacemaker Programmer 2030 intended for single-use or repeated use in clinical settings, and what maintenance considerations apply?

  The Pacemaker Programmer 2030 is explicitly supplied as a reusable device, meaning it is designed for repeated use in clinical environments by trained professionals like cardiologists or electrophysiologists. Since it is not sterile, it must be cleaned and maintained according to electromagnetic compatibility (EMC) and safety standards—not clinical sterility protocols. Regular calibration and adherence to manufacturer guidelines are essential to ensure reliable performance and patient safety.

• How do I confirm the regulatory status of the Pacemaker Programmer 2030, particularly regarding FDA clearance and compliance?

  The Pacemaker Programmer 2030 holds FDA 510(k) clearance (K820230) under the Traditional review pathway, classified as substantially equivalent (SESE) to a predicate device. It falls under 21 CFR 870.3700 for pacemaker programmers and is categorized under the KRG product code (Programmer, Pacemaker). For full details, refer to the FDA’s OpenFDA database using its k_number (K820230) or consult the manufacturer’s documentation for compliance and usage guidelines.

• What clinical specialties or healthcare professionals are authorized to use the Pacemaker Programmer 2030, and why?

  The Pacemaker Programmer 2030 is intended for use by trained medical personnel in the cardiovascular specialty, specifically cardiologists or electrophysiologists. This restriction aligns with its advisory committee designation (CV) and the complexity of programming and monitoring implanted pacemakers, which require specialized training to ensure accurate adjustments and patient safety. Only authorized personnel should operate it.