Cleared Traditional

K221962 - LINQ II Insertable Cardiac Monitor

K221962 is the FDA 510(k) clearance for LINQ II 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 51-day FDA review.

K221962 · Medtronic, Inc. · Cardiovascular device
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Aug 2022
Decision
51d
Days
Class 2
Risk

K221962 is an FDA 510(k) clearance for the LINQ II 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 August 25, 2022 after a review of 51 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 K221962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2022
Decision Date August 25, 2022
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K221962.
BIOMONITOR IV
K230375 · Biotronik, Inc. · May 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
K230553 · Medtronic, Inc. · Apr 2023
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
K223630 · Medtronic, Inc. · Apr 2023
BIOMONITOR IIIm, BIOMONITOR III
K221856 · Biotronik, Inc. · Jul 2022
Reveal LINQ Insertable Cardiac Monitor
K212008 · Medtronic, Inc. · Jul 2021
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
K210484 · Medtronic, Inc. · Jun 2021