Reveal Insertable Loop Recorder (ILR) System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K972242 FDA 510(k)
- FDA Product Code
- MXC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2800 FDA 510(k)
- Regulation Number
- 870.2800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- ST FDA 510(k)
The Reveal Insertable Loop Recorder (ILR) System is an implantable cardiac monitoring device designed to capture subcutaneous electrocardiograms (ECG) during symptomatic episodes. It is a patient-activated and automatically-activated monitoring system that records cardiac activity for patients at increased risk of cardiac arrhythmias or those experiencing transient symptoms such as dizziness, palpitation, syncope, and chest pain.
The Reveal ILR System is implanted subcutaneously and is not visible in most patients, providing continuous monitoring for up to three years. It is supplied as a single-use device and requires appropriate storage conditions. The device has received FDA 510(k) clearance with product code MXC and is classified under device class 2 for implantable cardiac recorders without arrhythmia detection.
Frequently asked questions
What is the Reveal Insertable Loop Recorder System used for?
The Reveal ILR System is an implantable cardiac monitoring device designed to capture subcutaneous electrocardiograms (ECG) during symptomatic episodes. It is used for patients at increased risk of cardiac arrhythmias or those experiencing transient symptoms such as dizziness, palpitation, syncope, and chest pain.
How is the Reveal ILR System supplied and what is its sterility status?
The Reveal ILR System is supplied as a single-use device and requires appropriate storage conditions. It is designed to be implanted subcutaneously and is not visible in most patients, providing continuous monitoring for up to three years.
What is the regulatory status of the Reveal ILR System?
The Reveal ILR System has received FDA 510(k) clearance with product code MXC and is classified under device class 2 for implantable cardiac recorders without arrhythmia detection. It is categorized as substantially equivalent and subject to tracking regulations.
How long does the Reveal ILR System monitor cardiac activity?
The Reveal ILR System provides continuous monitoring for up to three years after implantation. It is both patient-activated and automatically-activated to record cardiac activity during symptomatic episodes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Reveal LINQ™ insertable cardiac monitor - Medtronic, Reveal LINQ ICM System - Getting a Heart Monitor | Medtronic, PDF Reveal® Plus 9526
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972242 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K972242 24 fields · synced Oct 1, 2026