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Command Ultra II

by Cardiac Pacemakers, Inc. 2 variants

510(k) K830382

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830382 Date17 Mar 1983ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Command Ultra II is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing.

This device is supplied as a single-use implantable component and requires sterile handling during surgical implantation. It is regulated under FDA 510(k) clearance (K830382) and falls under the product code DXY, classified as a high-risk, life-sustaining cardiovascular device. Storage and handling must comply with sterile medical device protocols.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of heart conditions is the Command Ultra II designed to treat, and how does it work?

    The Command Ultra II is designed for patients with bradycardia or other conduction disorders that require chronic cardiac pacing. It works by delivering regulated electrical impulses to the heart muscle, helping to maintain a normal heart rhythm when the natural conduction system is impaired.

  • Is the Command Ultra II intended for single-use or can it be reused after implantation?

    The Command Ultra II is explicitly supplied as a single-use implantable component. It must be handled under sterile conditions during surgery and is not intended for reuse after implantation.

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

    The Command Ultra II follows the FDA 510(k) clearance pathway, specifically under clearance number K830382, and is classified as a Class III device under product code DXY. This classification indicates it is a high-risk, life-sustaining cardiovascular device, meaning it must meet stringent regulatory standards for safety and efficacy before use.

  • How should the Command Ultra II be stored and handled to ensure sterility?

    The Command Ultra II requires sterile handling during surgical implantation, so storage and handling must strictly comply with sterile medical device protocols. This ensures the device remains uncontaminated before use.