Suprima Model 254-24

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K852340 ↗

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 purpose of the Suprema Model 254-24 and how does it function in patients?

  The Suprema Model 254-24 is an implantable pacemaker pulse-generator designed to regulate and control the heartbeat in patients with bradycardia or cardiac conduction disorders. It delivers electrical impulses to the heart muscle to maintain a consistent rhythm, ensuring long-term cardiac support for individuals requiring chronic pacing.

• Is the Suprema Model 254-24 intended for single-use or reusable implantation, and how is it supplied?

  The device is intended for single-use implantation only and is supplied sterile, meaning it is ready for surgical use without additional sterilization. It must be implanted by qualified healthcare professionals in a controlled clinical setting.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Suprema Model 254-24 received FDA 510(k) clearance (K852340) under the Traditional 510(k) review pathway, with a decision code of SESE (Substantially Equivalent). It is classified as a Class III medical device (high-risk, life-sustaining) under product code DXY and regulation number 870.3610, requiring premarket approval due to its critical role in cardiac function.

• What medical specialty is primarily responsible for the use and oversight of this device?

  The Suprema Model 254-24 falls under the Cardiovascular medical specialty, meaning its use, implantation, and long-term management are typically handled by cardiologists, electrophysiologists, or cardiac surgeons specializing in pacemaker therapy.

• How is the device’s regulatory history documented, and what does the advisory committee involvement signify?

  The device’s regulatory history includes a submission date of June 3, 1985, and clearance on November 8, 1985, reviewed by the FDA’s Cardiovascular (CV) Advisory Committee. This involvement signifies that the device underwent expert evaluation to ensure safety and effectiveness for its intended use in managing bradycardia and conduction disorders.