Arcolith 3022&Arcolith 3023 Cardiac Gen.

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

510(k) Number

K800838 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Arcolith 2000 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K791715 Active Cleared 27 Sep 1979

• Unipolar Programmable Lithium Card. Gen.

  Class III

  FDA 510(k) K801241 Active Cleared 30 Jun 1980

• ArcoBiolith Pacemaker Model

  Class III

  FDA 510(k) K780776 Active Cleared 3 Oct 1978

• Decubitus Mattress

  Class I

  FDA 510(k) K760963 Active Cleared 18 Nov 1976

• Pacemaker & Cardiac Lead, Bipolar

  Class III

  FDA 510(k) K771262 Active Cleared 21 Jul 1977

• Implantable Heart Lead Terminal Adapter

  Class II

  FDA 510(k) K790436 Active Cleared 14 May 1979

See all devices from Arco Medical Products Co. →

• What is the primary purpose of the Arcolith 3022 & 3023 Cardiac Generator, and how does it function in a clinical setting?

  The Arcolith 3022 & 3023 are implantable pacemaker pulse-generators designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. They are surgically implanted to help manage abnormal heartbeats, ensuring proper pacing when the heart’s natural conduction system is compromised. These devices are classified as Class III due to their role in life-sustaining functions, requiring FDA pre-market approval.

• Are the Arcolith 3022 & 3023 devices intended for single-use or can they be reused after implantation?

  The Arcolith 3022 & 3023 are supplied sterile and explicitly intended for single-use only after surgical implantation. Reuse is not supported, as it could compromise sterility and device functionality, posing risks to patient safety. Proper sterile handling and storage protocols must be followed to maintain integrity.

• What regulatory pathway was followed for FDA clearance of these devices, and how does that affect their use?

  The Arcolith 3022 & 3023 received FDA 510(k) clearance (K800838) under the traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device. This clearance falls under product code DXY and adheres to 21 CFR 870.3610, ensuring compliance with FDA requirements for implantable pacemaker pulse-generators. Clinicians can rely on this clearance as evidence of safety and performance, though local institutional protocols may still apply.

• How should these devices be stored to ensure they remain effective and sterile until use?

  Since the Arcolith 3022 & 3023 are sterile and single-use, they must be stored in accordance with sterile medical device protocols to prevent contamination. The packaging should remain unopened until immediate preoperative use, and storage conditions (e.g., temperature, humidity) should align with manufacturer guidelines to preserve functionality and sterility. Always check expiration dates and integrity of the packaging before use.

• What advisory committee was involved in the review of these devices, and what does that imply about their clinical focus?

  The Arcolith 3022 & 3023 were reviewed by the FDA’s Cardiovascular (CV) Advisory Committee, which specializes in evaluating devices related to heart function and rhythm management. This committee’s involvement underscores the devices’ clinical focus on cardiac pacing and rhythm regulation, ensuring their design and performance align with cardiovascular safety standards. The advisory committee’s input helps validate the device’s role in managing life-sustaining cardiac functions.