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LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

by Medtronic, Inc.

510(k) K210484

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210484 Date11 Jun 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MXD
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is an insertable cardiac monitor designed for long-term heart monitoring. It records subcutaneous ECG and is indicated for adult patients and pediatric patients who are at least two years old with clinical syndromes or situations at increased risk of cardiac arrhythmias, or who experience transient symptoms such as dizziness.

The device is an insertable automatically activated and patient-activated monitoring system. It is supplied as a sterile, single-use implantable device and is indicated for use in clinical settings requiring extended cardiac rhythm monitoring. Regulatory authorization is based on FDA 510(k) clearance under product code MXD and regulation number 870.1025.

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Questions

AI-generated answers, 25 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 is the LINQ II Insertable Cardiac Monitor with Zelda AI ECG Classification System used for?

    It is designed for long-term heart monitoring by recording subcutaneous ECG in adult and pediatric patients aged at least two years who are at increased risk of cardiac arrhythmias or experience transient symptoms such as dizziness, enabling detection of arrhythmic events over extended periods.

  • How is the LINQ II Insertable Cardiac Monitor supplied and is it reusable?

    The device is supplied as a sterile, single-use implantable device, meaning it is intended for one-time implantation and cannot be reused after removal to ensure patient safety and maintain sterility.

  • What regulatory pathway authorized the LINQ II Insertable Cardiac Monitor with Zelda AI ECG System?

    The device received regulatory authorization through FDA 510(k) clearance, specifically under product code MXD and regulation number 870.1025, based on a determination of substantial equivalence to a predicate device.