Cleared Traditional

K230553 - LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230553 · Medtronic, Inc. · Cardiovascular device
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Apr 2023
Decision
57d
Days
Class 2
Risk

K230553 is an FDA 510(k) clearance for the LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application. 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 26, 2023 after a review of 57 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K230553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2023
Decision Date April 26, 2023
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 K230553.
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K233562 · Medtronic, Inc. · Dec 2023