# K251463: EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Sep 4, 2025 after 115 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K000248 (2000). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242016: EnSite™ X EP System, Abbott Medical (2024) Summary page 5.

## Indications for use
The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures. When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters. The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

Source page: https://510kreport.com/device/K251463
Methodology: https://510kreport.com/methodology