FDA Product Code MXD: Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Under FDA product code MXD, implantable cardiac event recorders with arrhythmia detection are cleared for long-term cardiac monitoring.
These subcutaneous devices continuously monitor the heart's electrical activity for up to three years, automatically storing ECG data when arrhythmias are detected or when the patient activates the device. They are used to diagnose unexplained syncope, palpitations, and cryptogenic stroke.
MXD devices are Class II medical devices, regulated under 21 CFR 870.1025 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Medtronic, Inc., Biotronik, Inc. and Boston Scientific Corporation.
FDA 510(k) Cleared Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) Devices (Product Code MXD)
About Product Code MXD - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code MXD since 2014, with 33 receiving FDA clearance (average review time: 87 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under MXD have taken an average of 61 days to reach a decision - down from 91 days historically, suggesting improved FDA processing for this classification.
MXD devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →