Cleared Traditional

K210484 - LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210484 · Medtronic, Inc. · Cardiovascular device
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Jun 2021
Decision
112d
Days
Class 2
Risk

K210484 is an FDA 510(k) clearance for the LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System. Classified as Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (product code MXD), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on June 11, 2021 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K210484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2021
Decision Date June 11, 2021
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

All 32
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