# K093942: Ensite Velocity System V1.3

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Feb 25, 2010 after 65 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
No predicates in its family tree.
119 later devices descend from it; 3 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K101419: Ensite Velocity System, Model EE3000 (2010), 66 descendants of its own
- K101667: Ensite Velocity System Referred to Ensite Velocity System with Positional Reference Tool (PRT) (2010), 50 descendants of its own
- K112688: Ensite Velocity System V.3.0 (2011), 48 descendants of its own
- K130594: Ensite Velocity System (2013), 46 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own

## Indications for use
The EnSite VelocityTM Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated. *When used with the EnSite Array'TM 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/K093942
Methodology: https://510kreport.com/methodology