Cleared Traditional

K150614 - Reveal LINQ

K150614 is the FDA 510(k) clearance for Reveal LINQ by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code MXD) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K150614 · Medtronic, Inc. · Cardiovascular device
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Aug 2015
Decision
149d
Days
Class 2
Risk

K150614 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 August 6, 2015 after a review of 149 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K150614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date August 06, 2015
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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
Devices cleared under the same product code (MXD) and FDA review panel - the closest regulatory comparables to K150614.
Reveal LINQ
K160809 · Medtronic, Inc. · May 2016
Reveal LINQ
K160689 · Medtronic, Inc. · Apr 2016
BioMonitor 2-AF, BioMonitor 2-S
K152995 · Biotronik, Inc. · Apr 2016
BioMonitor
K143503 · Biotronik, Inc. · Mar 2015
BIOMONITOR
K132960 · Biotronik, Inc. · Jun 2014
REVEAL LINQ INSERTABLE CARDIAC MONITOR
K132649 · Medtronic, Inc. · Feb 2014