Cleared Traditional

K162855 - Reveal LINQ

K162855 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 Traditional 510(k) pathway after a 134-day FDA review.

K162855 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
134d
Days
Class 2
Risk

K162855 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 February 23, 2017 after a review of 134 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

FDA 510(k) Submission Details - K162855

510(k) Number K162855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2016
Decision Date February 23, 2017
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 32
Devices cleared under the same product code (MXD) and FDA review panel - the closest regulatory comparables to K162855.
BIOMONITOR III, Remote Assistant III
K190548 · Biotronik, Inc. · Jul 2019
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
K171514 · Biotronik, Inc. · Jun 2017
BioMonitor 2-AF, BioMonitor 2-S
K170628 · Biotronik, Inc. · Mar 2017
Reveal LINQ Insertable Cardiac Monitor
K163460 · Medtronic, Inc. · Feb 2017
Reveal LINQ
K160809 · Medtronic, Inc. · May 2016
Reveal LINQ
K160689 · Medtronic, Inc. · Apr 2016