# K260212: EnSite™ X EP System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Apr 20, 2026 after 87 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: 21 generations back to K000248 (2000). 62 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251234: EnSite™ X EP System, Abbott Medical (2025) Summary page 5.
- K252013: EnSite™ X EP System, Abbott Medical (2025) Summary page 5.

## Most influential descendants
- K261729: EnSite™ X EP System (2026), 0 descendants of its own
- K262006: EnSite™ X EP System (2026), 0 descendants of its own

## Indications for use
EnSite™ X EP System 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 (EP) procedures. EnSite™ X EP System Contact Force Software License 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. EnSite™ X EP System Surface Electrode Kit 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/K260212
Methodology: https://510kreport.com/methodology