Ultra Software Module Model 2016

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

510(k) Number

K863046 ↗

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 is the primary purpose of the Ultra Software Module Model 2016 and how does it integrate with pacemaker systems?

  The Ultra Software Module Model 2016 is designed as a programmer for pacemaker systems, enabling healthcare professionals to perform programming, diagnostics, and patient data management in cardiovascular applications. It is not a standalone device but functions as a software module that interfaces with compatible pacemaker models, allowing clinicians to adjust pacing parameters, retrieve diagnostic information, and monitor patient status. This integration ensures seamless communication between the programmer and the implanted device, facilitating precise and tailored patient care.

• Is the Ultra Software Module Model 2016 intended for single-use or repeated use in clinical settings?

  The Ultra Software Module Model 2016 is not a single-use device. As a software-based programmer, it is intended for repeated use in clinical settings by trained healthcare professionals. The module is designed to be part of a durable programming system, allowing for ongoing patient management and diagnostics over time, provided it remains compatible with the connected pacemaker models.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Ultra Software Module Model 2016 received FDA 510(k) clearance under the traditional pathway, with a decision date of December 5, 1986. This classification means the device was determined to be substantially equivalent to a legally marketed predicate device at the time of review. Clinically, this indicates that the device has undergone FDA evaluation for safety and effectiveness in its intended use as a programmer for pacemakers, ensuring it meets regulatory standards for cardiovascular applications.

• Which pacemaker models is the Ultra Software Module Model 2016 compatible with, and how can I verify compatibility?

  The Ultra Software Module Model 2016 is compatible with multiple pacemaker models, as indicated by the listed FEI numbers (e.g., 3011120183, 2017865, etc.) in the regulatory data. These identifiers correspond to specific pacemaker systems registered with the FDA under the product code KRG (Cardiac Pacemakers, Implantable). To verify compatibility, check the device’s documentation or consult Cardiac Pacemakers, Inc. directly, as the module requires specific pacemaker model support to function properly.