Cleared Special

K240693 - LINQ II™ Insertable Cardiac Monitor (ICM)

K240693 is an FDA 510(k) clearance for LINQ II Insertable Cardiac Monitor (ICM), manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code MXD cleared through the Special 510(k) pathway after a 15-day FDA review.

K240693 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
15d
Days
Class 2
Risk

K240693 is an FDA 510(k) clearance for the LINQ II™ Insertable Cardiac Monitor (ICM). 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 March 28, 2024 after a review of 15 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.

FDA 510(k) Submission Details - K240693

510(k) Number K240693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2024
Decision Date March 28, 2024
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

MXD Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (MXD) and FDA review panel - the closest regulatory comparables to K240693.
Assert-IQ (DM5100)
K253516 · Abbott Medical · Dec 2025
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
K233562 · Medtronic, Inc. · Dec 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · Medtronic, Inc. · Oct 2023
LUX-Dx II (M302)
K231328 · Boston Scientific Corp · Aug 2023
K240693 · LINQ II™ Insertable Cardiac Monitor (ICM)
Download PDF FDA Summary Medtronic, Inc.