Cleared Special

K233562 - LINQ II Insertable Cardiac Monitor

K233562 is the FDA 510(k) clearance for LINQ II Insertable Cardiac Monitor by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code MXD) cleared through the Special 510(k) pathway after a 30-day FDA review.

K233562 · Medtronic, Inc. · Cardiovascular device
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Dec 2023
Decision
30d
Days
Class 2
Risk

K233562 is an FDA 510(k) clearance for the LINQ II Insertable Cardiac Monitor. 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 December 6, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K233562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2023
Decision Date December 06, 2023
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (MXD) and FDA review panel - the closest regulatory comparables to K233562.
Assert-IQ (DM5000)
K251221 · Abbott · Sep 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
K252593 · Boston Scientific Corporation · Sep 2025
LINQ II™ Insertable Cardiac Monitor (ICM)
K240693 · Medtronic, Inc. · Mar 2024
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · Medtronic, Inc. · Oct 2023
LUX-Dx II (M302)
K231328 · Boston Scientific Corp · Aug 2023
BIOMONITOR IV
K230375 · Biotronik, Inc. · May 2023