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Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K994331

by Medtronic Vascular

Identifiers

510(k) Number
K994331 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
SESE Substantially Equivalent FDA 510(k)

The Reveal Plus Insertable Loop Recorder System is an Implantable Cardiac Recorder, Event (Without Arrhythmia Detection) per FDA nomenclature. It is a subcutaneous implantable device designed to continuously monitor and record cardiac electrical signals (ECG) for diagnostic purposes. The system captures both patient-activated events and automatically detected arrhythmias, enabling long-term rhythm monitoring in patients with unexplained symptoms. Its primary function is to provide detailed ECG data during symptomatic episodes, aiding in the diagnosis of cardiac arrhythmias or other cardiac conditions.

The system consists of two components: the Model 9526 Implanted Recorder, a subcutaneous device implanted under the skin, and the Model 6191 Patient Activator, a handheld device used by patients to manually trigger recordings during symptomatic episodes. Supplied sterile and intended for single-use implantation, the device is classified as Class II under FDA regulations. It is intended for use in clinical settings by trained healthcare professionals and requires proper storage in accordance with manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

What is the Reveal Plus Insertable Loop Recorder System used for?

The Reveal Plus Insertable Loop Recorder System is designed to continuously monitor and record cardiac electrical signals (ECG) for diagnostic purposes. It captures both patient-activated events (using the Model 6191 Patient Activator) and automatically detected arrhythmias, helping clinicians diagnose unexplained cardiac symptoms or arrhythmias by providing detailed ECG data during symptomatic episodes.

How is the Reveal Plus Insertable Loop Recorder System supplied and intended for use?

The system is supplied sterile and intended for single-use implantation. It consists of two components: the Model 9526 Implanted Recorder, which is implanted under the skin, and the Model 6191 Patient Activator, a handheld device for manual recording triggers. It is intended for use in clinical settings by trained healthcare professionals only.

Is the Reveal Plus Insertable Loop Recorder System reusable or single-use?

The Reveal Plus Insertable Loop Recorder System is designed for single-use implantation. The implanted recorder (Model 9526) is not intended for reuse after implantation, and the Patient Activator (Model 6191) is also intended for single-use by one patient. Proper storage guidelines must be followed to maintain sterility and functionality.

What storage requirements apply to the Reveal Plus Insertable Loop Recorder System?

The system must be stored in accordance with the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging until ready for use, protected from contamination, and stored in a clean, dry environment as directed by Medtronic Vascular.

What regulatory pathway does the Reveal Plus Insertable Loop Recorder System follow?

The Reveal Plus Insertable Loop Recorder System follows the FDA’s 510(k) clearance pathway, classified as substantially equivalent under the Special 510(k) program. It was reviewed by the FDA’s Cardiovascular Advisory Committee and received clearance on January 21, 2000, under the product code MXC for Implantable Cardiac Recorders.

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 Plus Insertable Loop Recorder System, Model 9526 Implanted ..., PDF Reveal® Plus 9526, Reveal Plus Insertable Loop Recorder System Model 9526 Implantable ..., Medtronic Reveal Plus 9526 Manual + AI Chat | Manualzz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K994331 24 fields · synced Oct 5, 2026