# K130594: Ensite Velocity System

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: May 3, 2013 after 57 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: 3 generations back to K093942 (2010). 3 ancestors in all.
46 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112688: Ensite Velocity System V.3.0, St Jude Medical (2011) Summary page 2.

## Most influential descendants
- K141050: Ensite Velocity System (2014), 33 descendants of its own
- K160210: EnSite Precision Cardiac Mapping System v2.0 (2016), 29 descendants of its own
- K160218: AutoMark Module (2016), 28 descendants of its own
- K160187: Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (2016), 28 descendants of its own
- K172396: EnSite Velocity Cardiac Mapping System v5.2 (2018), 27 descendants of its own

## Indications for use
The EnSite Velocity Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated. *When used with the EnSite ArrayTM Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR *When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Source page: https://510kreport.com/device/K130594
Methodology: https://510kreport.com/methodology