Cleared Traditional

K132649 - REVEAL LINQ INSERTABLE CARDIAC MONITOR

K132649 is the FDA 510(k) clearance for REVEAL LINQ INSERTABLE CARDIAC MONITOR by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code MXD) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K132649 · Medtronic, Inc. · Cardiovascular device
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Feb 2014
Decision
172d
Days
Class 2
Risk

K132649 is an FDA 510(k) clearance for the REVEAL LINQ 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 February 14, 2014 after a review of 172 days - an extended review cycle.

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 K132649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2013
Decision Date February 14, 2014
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00680927 Completed Interventional Industry-sponsored

Reveal® XT Performance Trial (XPECT)

Reveal® XT Performance Trial

247
Patients (actual)
24
Sites
Open label
Masking
Condition studied Atrial Fibrillation; Risk of Cardiac Arrhythmias
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Guido H. Rieger, MD
Sponsor Medtronic BRC (industry)
Started 2007-09-01 → Primary completion 2008-08-01
Primary outcome
Atrial Fibrillation Burden (AF Burden)
Secondary outcome
AF episode detection accuracy and AF episode duration accuracy
Study completed - no results published. This trial concluded in 2008 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov