510(k) K253516
K253516 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Assert-IQ (DM5100)". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.1025. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2025
- Date Received
- November 12, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type