Command P5 Bipolar Pulse Generator

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

510(k) Number

K811402 ↗

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 purpose of the Command P5 Bipolar Pulse Generator, and how does it differ from other pacemakers in its approach to cardiac stimulation?

  The Command P5 Bipolar Pulse Generator is designed specifically to generate electrical pulses for cardiac pacing, helping patients with bradycardia or conduction disorders maintain a proper heart rhythm. Unlike some unipolar pacemakers, it uses bipolar electrode technology, which delivers stimulation more precisely by targeting a smaller area of heart tissue between two electrodes. This reduces the risk of stray currents and potential tissue irritation.

• Is the Command P5 intended for reuse, or is it meant to be implanted as a single-use device? How does this affect its clinical use?

  The Command P5 is explicitly intended for single-use implantation only, meaning it is not designed or approved for reuse. This limits its clinical use to one-time procedures, where the device is implanted permanently to provide long-term pacing support. Reuse is not supported by the manufacturer or regulatory clearance, so clinicians must follow standard protocols for single-use implantable devices.

• What regulatory pathway was followed for the FDA clearance of this device, and what does the product code (DXY) indicate about its classification?

  The Command P5 received FDA 510(k) clearance (K811402) under the Traditional 510(k) Review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. The product code DXY categorizes it under the Cardiovascular specialty and confirms its classification as a Class III device, which requires stringent regulatory oversight due to its role in life-sustaining or life-supporting functions like pacing.

• Are there any specific storage or handling instructions provided for the Command P5, or should it be treated like a standard implantable device?

  The provided regulatory data does not include specific storage or handling instructions beyond standard practices for implantable medical devices. As a single-use, sterile device, it should be stored in a clean, dry environment protected from contamination until implantation, following general aseptic techniques for surgical devices. Always refer to the manufacturer’s official labeling for any additional guidance.