Suprima II Model 254-28

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K852432 ↗

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 Suprema II Model 254-28 pacemaker, and who is it designed for?

  The Suprema II Model 254-28 is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering electrical impulses to the heart when natural contractions are insufficient. It is intended for patients who require permanent pacing to manage bradycardia or conduction disorders, ensuring consistent heart function when spontaneous beats are inadequate.

• Is this device intended for single-use or reusable implantation, and how should it be handled?

  The Suprema II Model 254-28 is supplied sterile and intended for single-use implantation only. Since it is sterile, it must be handled according to strict sterile medical device protocols to prevent contamination before use.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?

  The Suprema II Model 254-28 received FDA clearance through a Traditional 510(k) review under the product code DXY, with a decision of *Substantially Equivalent* (SESE). It was reviewed by the Cardiovascular (CV) Advisory Committee and originally authorized in 1985 under regulation 870.3610.

• How should this device be stored to maintain its integrity before implantation?

  Since the Suprema II Model 254-28 is sterile and intended for single-use, it must be stored in accordance with sterile medical device protocols. This typically includes keeping it in its original packaging, in a clean, dry environment, and away from extreme temperatures or contamination until immediate use.