# K223094: EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Dec 27, 2022 after 88 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: 17 generations back to K000248 (2000). 57 ancestors in all.
10 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)
- K221213: EnSite X EP System, Abbott (2022) Summary page 4.

## Most influential descendants
- 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
- K252013: EnSite™ X EP System (2025), 3 descendants of its own
- K260212: EnSite™ X EP System (2026), 2 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. 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. The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software Module is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use. The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software Module 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/K223094
Methodology: https://510kreport.com/methodology