Cleared Traditional

K122090 - SJM CONFIRM IMPLANTABLE CARDIAC MONITOR

K122090 is an FDA 510(k) clearance for SJM CONFIRM IMPLANTABLE CARDIAC MONITOR, manufactured by St. Jude Medical, Cardiac Rhythm Management Divisi. The device is a Class 2 Cardiovascular device with product code MXC cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K122090 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
122d
Days
Class 2
Risk

K122090 is an FDA 510(k) clearance for the SJM CONFIRM IMPLANTABLE CARDIAC MONITOR. Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on November 15, 2012 after a review of 122 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K122090

510(k) Number K122090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date November 15, 2012
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 22
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K122090.
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
SJM CONFIRM
K122161 · St Jude Medical · Nov 2012
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
K101968 · St Jude Medical · Sep 2010
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
K091206 · Transoma Medical · May 2009
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
K083828 · Transoma · Feb 2009
K122090 · SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
Download PDF FDA Summary St. Jude Medical, Car…