Cleared Traditional

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

K251221 · Abbott · Cardiovascular

Sep 2025

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K251221 is an FDA 510(k) clearance for the Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000), a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II — Special Controls, product code MXD), submitted by Abbott (Sylmar, US). The FDA issued a Cleared decision on September 17, 2025, 149 days after receiving the submission on April 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K251221 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2025
Decision Date	September 17, 2025
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1025