Command Ultra I Implantable Pacemaker Pulse-Generator

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

Full name

Command Ultra I

510(k) Number

K831161 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

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

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

• Micro Thin-PII, #0523

  Class III

  FDA 510(k) K802353 Active Cleared 22 Dec 1980

See all devices from Cardiac Pacemakers, Inc. →

• What types of patients is the Command Ultra I designed to support, and how does it address their needs?

  The Command Ultra I is designed for patients with bradycardia or other conduction disorders requiring chronic pacing support. It regulates cardiac rhythm by delivering programmable electrical impulses to the heart when spontaneous contractions are insufficient. The device adapts to physiological needs through programmable pacing rates and modes, ensuring consistent and reliable cardiac function for patients who rely on chronic pacing.

• Is the Command Ultra I intended for reuse, or is it meant to be implanted once and then discarded?

  The Command Ultra I is supplied sterile and intended for single-use implantation only. Once implanted beneath the skin—typically in the pectoral region—it is not designed for removal or reuse. Sterility and single-use protocols must be followed to maintain device integrity and patient safety.

• How should the Command Ultra I be handled and stored before implantation to ensure it remains effective?

  The Command Ultra I must be stored and handled according to sterile medical device protocols to preserve its integrity. Since it is supplied sterile, it should remain in its original packaging until immediately before use, following standard sterile field procedures for implantable devices. Avoid exposure to moisture, contamination, or physical damage.

• Can this device be used safely during MRI procedures, or are there specific precautions that must be taken?

  The Command Ultra I is MRI-unsafe and cannot be exposed to MRI environments without proper shielding. During imaging procedures, the device must be shielded to prevent interference or potential damage to both the pacemaker and the MRI system. Always consult radiology staff and follow institutional protocols for MRI-safe cardiac devices.

• What regulatory pathway was followed for the approval of the Command Ultra I, and which standards does it comply with?

  The Command Ultra I received FDA 510(k) clearance (K831161) under the traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. It complies with regulatory standards for implantable cardiac devices, including 21 CFR 870.3610, which governs implantable pacemaker pulse-generators. The device was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee.