# K101419: Ensite Velocity System, Model EE3000

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jun 11, 2010 after 22 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: 1 generation back to K093942 (2010). 1 ancestor in all.
66 later devices descend from it; 2 cite 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)
- K093942: Ensite Velocity System V1.3, St Jude Medical (2010) Summary page 2.

## Most influential descendants
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 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
- K182644: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), 26 descendants of its own

## Indications for use
The EnSite Velocity TM 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/K101419
Methodology: https://510kreport.com/methodology