Cleared Traditional

K972242 - REVEAL INSERTABLE LOOP RECORDER (ILR) S...

K972242 is the FDA 510(k) clearance for REVEAL INSERTABLE LOOP RECORDER (ILR) S... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code MXC) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K972242 · Medtronic Vascular · Cardiovascular device
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Jan 1998
Decision
214d
Days
Class 2
Risk

K972242 is an FDA 510(k) clearance for the REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM. Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 16, 1998 after a review of 214 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 Medtronic Vascular devices

Submission Details

510(k) Number K972242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 16, 1997
Decision Date January 16, 1998
Days to Decision 214 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 125d · This submission: 214d
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 15
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K972242.
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