Lithicron Model 0401 Pacemaker

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

510(k) Number

K791095 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lithicron II 0403 Implantable Pacemaker

  Class III

  FDA 510(k) K791678 Active Cleared 7 Sep 1979

• Lithicron Model 3-70C-B Pulse Generator

  Class III

  FDA 510(k) K771538 Active Cleared 22 Aug 1977

• Lithicron 0520 P-Synchroneous Pulse Gen.

  Class III

  FDA 510(k) K792609 Active Cleared 19 Nov 1980

• Lithicron F Programmable Pulse Gen

  Class III

  FDA 510(k) K780430 Active Cleared 22 Dec 1978

• Quintrex 0516 Prog. Pulse Generator Sys

  Not classified

  FDA 510(k) K802224 Active Cleared 12 Sep 1980

• Pulse Generator, Litkicron Model 3-70H

  Class III

  FDA 510(k) K770507 Active Cleared 7 Apr 1977

See all devices from Medcor, Inc. →

• What is the Lithicron Model 0401 Pacemaker primarily used for in clinical practice?

  The Lithicron Model 0401 Pacemaker is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when necessary. It is intended for patients with bradycardia or other cardiac conduction disorders that require artificial pacing, helping maintain a consistent and healthy heart rate.

• Is the Lithicron Model 0401 Pacemaker intended for single-use or can it be reused?

  The Lithicron Model 0401 Pacemaker is explicitly supplied sterile and intended for single-use implantation only. It must be implanted by a qualified healthcare professional and is not designed for reuse.

• How should the Lithicron Model 0401 Pacemaker be stored before use?

  While the device data does not specify storage conditions, as a sterile, implantable medical device, it should be stored in its original packaging in a clean, dry environment, protected from physical damage and extreme temperatures. Always follow the manufacturer’s instructions for optimal preservation.

• Can this pacemaker be used in an MRI environment, and if not, what precautions should be taken?

  The Lithicron Model 0401 Pacemaker is labeled as MRI-unspecified, meaning its safety in MRI environments has not been established. Therefore, it should not be used in MRI settings unless explicitly approved by the manufacturer for a specific MRI protocol. Always consult the manufacturer’s instructions to ensure patient safety.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The Lithicron Model 0401 Pacemaker received a Traditional 510(k) clearance (K791095) with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared pacemaker, ensuring it meets safety and effectiveness standards for treating bradycardia or conduction disorders.