# K213364: EnSite X EP System

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Nov 11, 2021 after 30 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: 15 generations back to K000248 (2000). 55 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212061: EnSite X EP System, Abbott (2021). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K221213: EnSite X EP System (2022), 11 descendants of its own
- K223094: EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License (2022), 10 descendants of its own
- K231415: EnSite™ X EP System (2023), 9 descendants of its own
- K242016: EnSite™ X EP System (2024), 8 descendants of its own
- K251234: EnSite™ X EP System (2025), 4 descendants of its own

## 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 (EP) procedures.

Source page: https://510kreport.com/device/K213364
Methodology: https://510kreport.com/methodology