Suprima II Model 254-26

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K852431 ↗

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 clinical condition is this device intended to address, and how does it work?

  The Suprema II Model 254-26 is designed to address bradycardia or conduction disorders by regulating cardiac rhythm. It functions as an implantable pacemaker pulse-generator, delivering controlled electrical impulses to the heart to maintain a proper heartbeat when the natural conduction system fails.

• Is this device intended for reuse, or is it meant to be implanted as a single-use device?

  This device is explicitly intended for single-use implantation. It is supplied sterile and must be implanted by qualified healthcare professionals in a clinical setting, ensuring patient safety and proper functionality.

• What regulatory pathway was followed for this device’s clearance, and which committee reviewed it?

  The Suprema II Model 254-26 followed the FDA’s 510(k) clearance pathway, specifically under the traditional review process. It was classified as substantially equivalent (SESE) and reviewed by the Cardiovascular (CV) Advisory Committee.

• Can this device be used in patients who require MRI procedures, or are there specific safety concerns?

  This device is explicitly not MRI-safe. It must be handled with care, and MRI procedures should be avoided to prevent interference with its functionality or potential harm to the patient.

• How is the device supplied, and what precautions should be taken during handling?

  The device is supplied sterile and intended for direct implantation by trained professionals. Since it is single-use, proper sterile techniques must be followed during handling to prevent contamination and ensure safe implantation.