510(k) K251221

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) by Abbott — Product Code MXD

K251221 is an FDA 510(k) premarket notification submitted by Abbott for the device "Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)". The FDA issued a decision of Substantially Equivalent on September 17, 2025. The device falls under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.1025. Abbott has at least 10 other 510(k) clearances on record.