Cleared Special

K262735 - LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)

K262735 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 28-day FDA review.

K262735 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
28d
Days
Class 2
Risk

K262735 is an FDA 510(k) clearance for the LINQ II Insertable Cardiac Monitor (ICM) (LNQ22). 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 August 28, 2026 after a review of 28 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

FDA 510(k) Submission Details - K262735

510(k) Number K262735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2026
Decision Date August 28, 2026
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 K262735.
BIOMONITOR IV (471155)
K261074 · Biotronik, Inc. · May 2026
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 (ICM)
K240693 · Medtronic, Inc. · Mar 2024
LINQ II Insertable Cardiac Monitor
K233562 · Medtronic, Inc. · Dec 2023