Cleared Traditional

K163407 - Confirm Rx Insertable Cardiac Monitor (...

K163407 is an FDA 510(k) clearance for Confirm Rx Insertable Cardiac Monitor (..., manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MXC cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K163407 · St. Jude Medical, Inc. · Cardiovascular device
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Sep 2017
Decision
298d
Days
Class 2
Risk

K163407 is an FDA 510(k) clearance for the Confirm Rx Insertable Cardiac Monitor (ICM) System. Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Sylmar, US). The FDA issued a Cleared decision on September 29, 2017 after a review of 298 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 St. Jude Medical, Inc. devices

FDA 510(k) Submission Details - K163407

510(k) Number K163407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date September 29, 2017
Days to Decision 298 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
173d slower than avg
Panel avg: 125d · This submission: 298d
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 K163407.
Confirm Rx Insertable Cardiac Monitor
K190295 · Abbott (St. Jude Medical) · Apr 2019
Confirm Rx Insertable Cardiac Monitor
K182981 · Abbott · Mar 2019
myMerlin(TM) Mobile Application Model APP1001
K173232 · St Jude Medical · Nov 2017
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
K133481 · St. Jude Medical, Inc. · May 2014
SJM CONFIRM
K122161 · St Jude Medical · Nov 2012
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
K101968 · St Jude Medical · Sep 2010