Cyberlith I Pulse Generator Model 253-04

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810385 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical purpose of the Cyberlith I Pulse Generator Model 253-04, and how does it function in patients?

  The Cyberlith I Pulse Generator Model 253-04 is designed to regulate heart rhythm in patients with bradycardia or cardiac conduction disorders by generating and delivering electrical impulses. It serves as an implantable pacemaker, ensuring consistent cardiac pacing to maintain proper heart function.

• Is the Cyberlith I Pulse Generator Model 253-04 intended for reuse, or is it meant for single-use implantation?

  The Cyberlith I Pulse Generator Model 253-04 is supplied sterile and intended for single-use implantation only. This ensures patient safety and sterility during surgical placement by trained medical professionals.

• How was the regulatory pathway for this device determined, and what advisory committee was involved in its review?

  The Cyberlith I Pulse Generator Model 253-04 was reviewed under the Traditional 510(k) pathway and classified as substantially equivalent (SESE) to a predicate device. Its review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a high-risk, life-sustaining Class III device.

• What type of surgical expertise is required for implantation of this device, and why?

  The Cyberlith I Pulse Generator Model 253-04 requires proper surgical placement by trained medical professionals, as it is an implantable device intended for cardiovascular use. Its precise implantation is critical for effective cardiac pacing and patient safety.

• What does the product code (DXY) indicate about the regulatory classification of this device?

  The product code DXY categorizes the Cyberlith I Pulse Generator Model 253-04 under Implantable Pacemaker Pulse-Generators, confirming its classification as a Class III medical device—a designation for high-risk, life-sustaining or life-supporting devices under FDA regulations.