Command Ultra I

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

510(k) Number

K820231 ↗

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

• 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 clinical purpose of the Command Ultra I pacemaker and for which patients is it intended?

  The Command Ultra I is designed to regulate cardiac rhythm by delivering electrical impulses to the heart when natural contractions are insufficient. It is intended for patients with bradycardia or conduction disorders requiring chronic pacing support, such as those with slow heart rates or improper electrical signaling between the heart’s chambers.

• How is the Command Ultra I supplied and what are its usage restrictions regarding sterility and patient reuse?

  The Command Ultra I is a reusable, non-sterile device intended for single-patient use after surgical implantation. It is not pre-sterilized for repeated use in multiple patients, so it must be dedicated to one patient following its initial implantation.

• Are there any specific storage instructions provided for the Command Ultra I, and what should clinicians consider regarding MRI safety?

  The provided data does not include specific storage conditions for the Command Ultra I. Additionally, no MRI safety information is detailed, so clinicians should exercise caution and consult manufacturer guidelines or medical literature before exposing patients with this device to MRI procedures.

• What regulatory pathway and clearance status does the Command Ultra I hold in the United States?

  The Command Ultra I holds an FDA 510(k) clearance (K820231) under the Traditional review pathway, with a decision date of March 15, 1982. It is classified under product code DXY and falls under Class III regulatory requirements, though the clearance itself indicates it was determined to be substantially equivalent to a predicate device at the time of approval.