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Unilith 7540 Pulse Generator

by Ela Medical, Inc.

510(k) K810887

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810887 Date20 Jul 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Ela Medical Unilith 7540 Pulse Generator
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 Unilith 7540 Pulse Generator is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is classified as a Class III medical device under FDA regulations, intended for use in patients requiring cardiac pacing to manage bradycardia or other conduction disorders.

This device is supplied sterile and intended for single-use implantation. It is regulated under FDA 510(k) clearance (K810887) and falls under the product code DXY, adhering to regulation number 870.3610. The pulse generator is intended for use in cardiovascular settings and must be implanted by qualified medical professionals following sterile procedures.

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