Cleared Special

K160689 - Reveal LINQ

K160689 is an FDA 510(k) clearance for Reveal LINQ, 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 42-day FDA review.

K160689 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
42d
Days
Class 2
Risk

K160689 is an FDA 510(k) clearance for the Reveal LINQ. 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 April 22, 2016 after a review of 42 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 - K160689

510(k) Number K160689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2016
Decision Date April 22, 2016
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
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 K160689.
Reveal LINQ
K162855 · Medtronic, Inc. · Feb 2017
Reveal LINQ Insertable Cardiac Monitor
K163460 · Medtronic, Inc. · Feb 2017
Reveal LINQ
K160809 · Medtronic, Inc. · May 2016
BioMonitor 2-AF, BioMonitor 2-S
K152995 · Biotronik, Inc. · Apr 2016
Reveal LINQ
K150614 · Medtronic, Inc. · Aug 2015
BioMonitor
K143503 · Biotronik, Inc. · Mar 2015