Cleared Traditional

K972242 - REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM

K972242 is an FDA 510(k) clearance for REVEAL INSERTABLE LOOP RECORDER (ILR) S..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K972242

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.

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 18
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