Cleared Special

Assert-IQ (DM5100)

K253516 · Abbott Medical · Cardiovascular

Dec 2025

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K253516 is an FDA 510(k) clearance for the Assert-IQ (DM5100), a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II — Special Controls, product code MXD), submitted by Abbott Medical (Sylmar, US). The FDA issued a Cleared decision on December 18, 2025, 36 days after receiving the submission on November 12, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K253516 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2025
Decision Date	December 18, 2025
Days to Decision	36 days
Submission Type	Special
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