Cleared Traditional

K223630 - Reveal LINQ Insertable Cardiac Monitor

K223630 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 121-day FDA review.

K223630 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
121d
Days
Class 2
Risk

K223630 is an FDA 510(k) clearance for the Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, A.... 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 5, 2023 after a review of 121 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K223630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2022
Decision Date April 05, 2023
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 K223630.
LUX-Dx II (M302)
K231328 · Boston Scientific Corp · Aug 2023
BIOMONITOR IV
K230375 · Biotronik, Inc. · May 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
K230553 · Medtronic, Inc. · Apr 2023
LINQ II Insertable Cardiac Monitor
K221962 · Medtronic, Inc. · Aug 2022
BIOMONITOR IIIm, BIOMONITOR III
K221856 · Biotronik, Inc. · Jul 2022
Reveal LINQ Insertable Cardiac Monitor
K212008 · Medtronic, Inc. · Jul 2021