# K253516: Assert-IQ (DM5100)

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Dec 18, 2025 after 36 days
- Product code: MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K190295 (2019). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251221: Assert-IQ  (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000), Abbott (2025) Summary page 5.

## Indications for use
The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ™ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ™ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ™ ICM has not been specifically tested for pediatric use.

Source page: https://510kreport.com/device/K253516
Methodology: https://510kreport.com/methodology