Handheld Pacemaker Programmer & Softwar

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

510(k) Number

K842364 ↗

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 clinical environments is this handheld pacemaker programmer designed for and how is it typically used?

  This device is specifically designed for use in clinical settings such as hospitals, cardiac care units, and outpatient electrophysiology labs. It interfaces with implantable pacemakers to allow healthcare professionals to remotely program pacing parameters, retrieve diagnostic data, and check battery status. This ensures precise cardiac rhythm management for patients with implanted pacemakers, enabling real-time adjustments and monitoring.

• Is the handheld pacemaker programmer reusable or single-use, and what maintenance is required?

  The handheld pacemaker programmer is a reusable electronic device paired with proprietary software. Since it is not a sterile instrument, sterilization is not required. However, it must be maintained according to the manufacturer’s guidelines to ensure accuracy, reliability, and proper functionality over time.

• Can this device be used safely in MRI environments, and what precautions should be taken?

  The handheld pacemaker programmer operates within MRI-safe parameters as defined by its specifications. However, before use in an MRI environment, it is critical to verify specific compatibility with the MRI system in question. This ensures no interference or safety risks arise during imaging procedures.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its use?

  This device was authorized through the FDA’s 510(k) clearance process (K842364), classified as a Class III medical device under FDA regulations. The