Cleared Traditional

K182981 - Confirm Rx Insertable Cardiac Monitor

K182981 is an FDA 510(k) clearance for Confirm Rx Insertable Cardiac Monitor, manufactured by Abbott. The device is a Class 2 Cardiovascular device with product code MXC cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K182981 · Abbott · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2019
Decision
151d
Days
Class 2
Risk

K182981 is an FDA 510(k) clearance for the Confirm Rx Insertable Cardiac Monitor. Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by Abbott (Sylmar, US). The FDA issued a Cleared decision on March 29, 2019 after a review of 151 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Abbott devices

FDA 510(k) Submission Details - K182981

510(k) Number K182981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2018
Decision Date March 29, 2019
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXC Device Classification - Class 2, Special Controls

Product Code MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

All 17
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K182981.
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
K193310 · Abbott (St. Jude Medical) · Mar 2020
Confirm Rx Insertable Cardiac Monitor
K192593 · Abbott · Oct 2019
Confirm Rx Insertable Cardiac Monitor
K190295 · Abbott (St. Jude Medical) · Apr 2019
myMerlin(TM) Mobile Application Model APP1001
K173232 · St Jude Medical · Nov 2017
Confirm Rx Insertable Cardiac Monitor (ICM) System
K163407 · St. Jude Medical, Inc. · Sep 2017
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
K133481 · St. Jude Medical, Inc. · May 2014