Lithium Pacemaker 811-811L & 811XL

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

510(k) Number

K840748 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Omikron Pacemaker 837 Unipolar & 838 Bipolar

  Class II

  FDA 510(k) K844277 Active Cleared 15 Feb 1985

• Modified Manufacturing Process for Omiderm(Tm)

  Class I

  FDA 510(k) K874480 Active Cleared 22 Feb 1988

• Omiband

  Class I

  FDA 510(k) K904445 Active Cleared 6 Mar 1991

• What types of heart conditions is this pacemaker designed to treat, and how does it work?

  This device is specifically designed for patients with bradycardia (slow heart rate) or other conduction disorders that require chronic pacing support. It works by delivering regulated electrical impulses to the heart muscle, helping to maintain a normal heart rhythm. The lithium battery ensures reliable, long-term function, making it suitable for patients needing consistent pacing over extended periods.

• Is this pacemaker intended for reuse, or is it meant to be implanted once and discarded?

  The Lithium Pacemaker 811-811L & 811XL is sterile and intended for single-use implantation only. It is not designed for reuse, and each unit is meant to be implanted by qualified healthcare professionals in controlled clinical settings like cardiac catheterization labs or operating rooms.

• What distinguishes the 811L and 811XL models from the standard 811 model?

  The 811L and 811XL models are lithium battery-powered variants, which provide extended operational life compared to earlier mercury-based pacemakers. While the exact differences in pacing capabilities or features aren’t specified, the lithium battery is a key upgrade for long-term reliability. The base 811 model is not explicitly described as lithium-powered in the provided data.

• How should this device be stored before implantation, and what precautions should be taken?

  Since the device is sterile and single-use, it should be stored in its original packaging under clean, dry conditions away from direct sunlight or extreme temperatures. The packaging must remain intact until use to maintain sterility. Implantation should only be performed by qualified professionals in a sterile clinical environment, such as an operating room or cardiac catheterization lab.

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

  This device received FDA 510(k) clearance (K840748) under the Traditional 510(k) Review pathway, determined to be substantially equivalent to predicate devices. This means the FDA reviewed it against existing pacemakers and confirmed it meets safety and effectiveness standards. Clinicians can rely on this clearance as evidence of regulatory compliance, though individual patient suitability should still be assessed by a cardiologist or electrophysiologist.