Cleared Traditional

K251221 - Assert-IQ (DM5000)

Also marketed or referenced as:
Assert-IQ (DM5300) Assert-IQ (DM5500) Merlin.net (MN7000)

K251221 is an FDA 510(k) clearance for Assert-IQ (DM5000), manufactured by Abbott. The device is a Class 2 Cardiovascular device with product code MXD cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K251221 · Abbott · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
149d
Days
Class 2
Risk

K251221 is an FDA 510(k) clearance for the Assert-IQ (DM5000). Classified as Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (product code MXD), Class II - Special Controls.

Submitted by Abbott (Sylmar, US). The FDA issued a Cleared decision on September 17, 2025 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott devices

FDA 510(k) Submission Details - K251221

510(k) Number K251221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXD Device Classification - Class 2, Special Controls

Product Code MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

All 32
Devices cleared under the same product code (MXD) and FDA review panel - the closest regulatory comparables to K251221.
BIOMONITOR IV (471155)
K261074 · Biotronik, Inc. · May 2026
Assert-IQ (DM5100)
K253516 · Abbott Medical · Dec 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
K252593 · Boston Scientific Corporation · Sep 2025
LINQ II™ Insertable Cardiac Monitor (ICM)
K240693 · Medtronic, Inc. · Mar 2024
LINQ II Insertable Cardiac Monitor
K233562 · Medtronic, Inc. · Dec 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · Medtronic, Inc. · Oct 2023