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Multilith Pulse Generator #1140

by Ela Medical, Inc.

510(k) K810489

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 NumberK810489 Date29 May 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  • Withdrawn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)

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 Multilith Pulse Generator #1140 is an implantable pacemaker pulse-generator, designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. This device is classified as a Class III medical device, reflecting its high-risk nature and critical role in sustaining life.

This pulse-generator is intended for surgical implantation and is regulated under FDA 510(k) clearance (K810489) with a traditional review process. It is supplied as a sterile, single-use device and must be implanted by a qualified healthcare professional in a controlled clinical setting. The device adheres to regulatory standards outlined in 21 CFR 870.3610 and is associated with cardiovascular applications, as documented in the FDA’s OpenFDA database.

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