Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) is an AI-enabled medical device from Abbott, listed by FDA (510(k), K251221) with a decision date of 2025-09-17. Review panel: Cardiovascular.
| FDA submission number | K251221 |
|---|---|
| Pathway | 510(k) |
| Company | Abbott |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-09-17 |
| Decision | Substantially Equivalent |
| Product code | MXD |
| Classification | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) |
| Device class | 2 |
| Regulation number | 870.1025 |
| Review time (calendar days) | 149 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.