Cleared Special

K101968 - SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A

K101968 is an FDA 510(k) clearance for SJM CONFIRM ICM, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code MXC cleared through the Special 510(k) pathway after a 65-day FDA review.

K101968 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
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Sep 2010
Decision
65d
Days
Class 2
Risk

K101968 is an FDA 510(k) clearance for the SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A. Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by St Jude Medical (Sunnyvale, US). The FDA issued a Cleared decision on September 15, 2010 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all St Jude Medical devices

FDA 510(k) Submission Details - K101968

510(k) Number K101968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2010
Decision Date September 15, 2010
Days to Decision 65 days
Submission Type Special
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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

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 20
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K101968.
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
K133481 · St. Jude Medical, Inc. · May 2014
SJM CONFIRM
K122161 · St Jude Medical · Nov 2012
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
K122090 · St. Jude Medical, Cardiac Rhythm Management Divisi · Nov 2012
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
K081365 · St Jude Medical · Aug 2008
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
K073147 · Transoma Medical · Dec 2007
SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
K063035 · Transnoma Medical, Inc. · Oct 2007