Cleared Traditional

SJM CONFIRM (K122161) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122161 · St Jude Medical · Cardiovascular device
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Nov 2012
Decision
131d
Days
Class 2
Risk

K122161 is an FDA 510(k) clearance for the SJM CONFIRM. 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 November 28, 2012 after a review of 131 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.

View all St Jude Medical devices

Submission Details

510(k) Number K122161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2012
Decision Date November 28, 2012
Days to Decision 131 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 125d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K122161.
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K173232 · St Jude Medical · Nov 2017
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K011098 · Medtronic Vascular · May 2001
REVEAL PLUS INSERTABLE LOOP RECORDER
K003667 · Medtronic Vascular · Feb 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K994331 · Medtronic Vascular · Jan 2000