Command Ultra II

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

510(k) Number

K831216 ↗

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 types of patients is the Command Ultra II designed to support, and how does it work?

  The Command Ultra II is designed for patients with bradycardia or other cardiac conduction disorders that require chronic pacing support. It functions as an implantable pacemaker pulse-generator, delivering regulated electrical impulses to the heart muscle to maintain a proper heart rhythm when the natural conduction system fails.

• Is the Command Ultra II intended for reuse, or is it a single-use device?

  The Command Ultra II is explicitly supplied as a single-use implantable component. It is intended for one-time surgical implantation by qualified healthcare professionals and is not designed for reuse.

• What regulatory pathway does the Command Ultra II follow, and what does that mean for its use?

  The Command Ultra II is regulated under the FDA’s 510(k) clearance process (K831216) as a Class III medical device, meaning it has undergone a thorough review to demonstrate substantial equivalence to a predicate device. This clearance confirms it meets FDA safety and effectiveness standards for use as an implantable pacemaker pulse-generator in a sterile operating environment.

• Are there any special considerations for storage or handling of the Command Ultra II before implantation?

  While the provided data does not specify storage conditions, the Command Ultra II is an implantable device intended for surgical use in a sterile environment. It should be handled according to standard sterile medical device protocols to ensure patient safety and device integrity prior to implantation.