Arcolith 4000 Implantable Pacemaker Pulse-Generator

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

Full name

Arcolith 4000

510(k) Number

K791165 ↗

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

• Arcolith 3022&Arcolith 3023 Cardiac Gen.

  Class III

  FDA 510(k) K800838 Active Cleared 4 Jun 1980

• Pacemaker & Cardiac Lead, Bipolar

  Class III

  FDA 510(k) K771262 Active Cleared 21 Jul 1977

See all devices from Arco Medical Products Co. →

• What is the primary purpose of the Arcolith 4000 pacemaker, and who should consider using it?

  The Arcolith 4000 is designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart, specifically for patients with chronic bradycardia or conduction disorders. It is intended for long-term use in individuals who require consistent cardiac pacing to maintain a stable heart rate.

• Is the Arcolith 4000 meant for reuse, or is it a single-use device?

  The Arcolith 4000 is explicitly labeled as a single-use implantable device. It is supplied sterile and intended for one-time implantation by qualified healthcare professionals in a clinical setting, ensuring patient safety and device efficacy.

• Can this device be used in patients who require MRI scans, or are there restrictions?

  The Arcolith 4000 is explicitly noted as not MRI-safe. Patients with this device should avoid MRI procedures, as the electromagnetic fields could interfere with its function or pose safety risks.

• How is the Arcolith 4000 regulated in the U.S., and what does that mean for clinicians?

  The Arcolith 4000 is classified as a Class III medical device under FDA regulations and has received 510(k) clearance (K791165). This means it undergoes rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness before clinical use. Clinicians can rely on its regulatory history as evidence of compliance with U.S. standards for implantable pacemakers.

• What storage or handling precautions should be taken with the Arcolith 4000 before implantation?

  While specific storage instructions aren’t detailed in the data, the device is supplied sterile and intended for single-use in a clinical setting. It should be handled with care to maintain sterility and integrity until implantation. Since it’s not MRI-safe, proper labeling and patient awareness are critical to prevent accidental exposure to MRI environments.