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Suprima II Model 253-23

by Intermedics, Inc. 510(k)

Active United States

510(k) K852430

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852430 Date17 Jul 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Suprema II Model 253-23 is an implantable pacemaker pulse-generator, designed to regulate and control the electrical impulses of the heart. It is classified as a Class III medical device and is intended for patients requiring cardiac pacing to maintain proper heart rhythm.

This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in a clinical setting. It is regulated under FDA 510(k) clearance (K852430) and adheres to the regulatory requirements outlined in 870.3610. The device is MRI-unspecified and must be handled and stored according to manufacturer guidelines to ensure proper functionality and sterility.

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