Command NP Implantable Pacemaker Pulse-Generator

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

Full name

Command Np

510(k) Number

K822309 ↗

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 heart conditions is the Command NP designed to treat, and how does it work?

  The Command NP is specifically designed for patients with bradycardia or conduction disorders that require chronic cardiac pacing. It regulates abnormal heart rhythms by delivering programmable electrical impulses to the heart muscle, helping to restore normal heart function. The device is intended for long-term use in patients whose natural pacemaker signals are too slow or irregular.

• Is the Command NP meant for single-use or can it be reused in a clinical setting?

  The Command NP is supplied sterile and intended for single-use implantation. However, it may be reused under specific institutional protocols, provided sterile handling and controlled clinical procedures are followed. Reuse should only occur in settings where strict sterility and safety protocols are maintained.

• What special handling or storage requirements does the Command NP have to ensure proper functionality?

  The Command NP must be handled using sterile techniques in a controlled clinical setting due to its sterile packaging. Storage must adhere to the manufacturer’s guidelines to preserve both sterility and functionality. Additionally, the device is not MRI-safe, so it should be stored and used in environments where MRI exposure is not a concern.

• How was the regulatory approval for the Command NP determined, and what does that mean for its use?

  The Command NP received FDA 510(k) clearance under the traditional review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it is as safe and effective as a previously approved device and meets regulatory standards for implantable cardiac devices (21 CFR 870.3610). Clinicians can rely on this approval for its intended use in treating bradycardia or conduction disorders.