510(k) · Cardiovascular

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

by Medtronic, Inc.

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is an AI-enabled medical device from Medtronic, Inc. that the U.S. FDA cleared through 510(k) K210484 on June 11, 2021. Its lead review panel is Cardiovascular and its primary product code is MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)).

See also FDA-cleared AI cardiovascular devices in 2021, all FDA AI clearances in 2021, top cardiovascular AI devices.

Key facts

Submission numberK210484
Pathway510(k)
Date of final decision
Company (FDA list)Medtronic, Inc.
Lead review panelCardiovascular
Primary product codeMXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Applicant (openFDA)Medtronic, Inc.
Applicant locationMounds View, MN, US
Device classClass 2
Regulation number21 CFR 870.1025
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System went through this pathway (K210484).

openFDA lists it as a Class 2 device under 21 CFR 870.1025. Class II devices are moderate risk and are subject to general and special controls.

Product code MXD covers 8 devices on the FDA AI list. By decision date, this device is #2 of 8 under that code. Medtronic, Inc. has 7 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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