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Micropulse 22U

by Edwards Pacemaker Systems

510(k) K780091

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 NumberK780091 Date30 Jan 1978ClearedStatusActive

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  • Withdrawn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 Micropulse 22U is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate cardiac rhythm by delivering electrical impulses to the heart when spontaneous contractions are insufficient. This device is intended for patients requiring chronic pacing support, including those with bradycardia or conduction system disorders.

The Micropulse 22U is supplied as a single-use, implantable device and is regulated under FDA 510(k) clearance (K780091) with a Traditional review pathway. It is classified under device class 3 and medical specialty Cardiovascular, with regulatory number 870.3610. No MRI safety or reusable specifications are indicated in the data.

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Questions

AI-generated answers, 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.

  • What types of patients is the Micropulse 22U designed to support with pacing therapy?

    The Micropulse 22U is designed for patients who require chronic pacing support due to bradycardia (slow heart rate) or conduction system disorders, where the heart’s natural electrical system fails to maintain adequate rhythm.

  • Is the Micropulse 22U intended for reuse or is it a single-use device?

    The Micropulse 22U is explicitly supplied as a single-use, implantable pulse-generator. It is not designed for reuse after implantation.

  • How is the regulatory pathway for the Micropulse 22U defined, and what does this mean for its use?

    The Micropulse 22U is regulated under the FDA’s 510(k) clearance pathway with a Traditional review, classified as a Class III device. This means it underwent a thorough evaluation by the FDA to demonstrate safety and effectiveness before market authorization, ensuring it meets stringent standards for implantable cardiac devices.

  • Are there any specific storage requirements mentioned for the Micropulse 22U?

    The provided data does not specify storage conditions for the Micropulse 22U. However, as an implantable device, it should generally be stored according to manufacturer guidelines to maintain sterility and functionality until use.