Assert-IQ (DM5100) is an AI-enabled medical device from Abbott Medical, listed by FDA (510(k), K253516) with a decision date of 2025-12-18. Review panel: Cardiovascular.
| FDA submission number | K253516 |
|---|---|
| Pathway | 510(k) |
| Company | Abbott Medical |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-12-18 |
| 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) | 36 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Abbott Medical · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.