# K110549: Ensite Velocity System

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: May 5, 2011 after 69 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: 2 generations back to K093942 (2010). 2 ancestors in all.
29 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101667: Ensite Velocity System Referred to Ensite Velocity System with Positional Reference Tool (PRT), St Jude Medical (2010) Summary page 1.

## Most influential descendants
- 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
- K183128: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), 25 descendants of its own
- K201181: EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System (2020), 18 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 Array™ 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 (ER) catheters in the heart.

Source page: https://510kreport.com/device/K110549
Methodology: https://510kreport.com/methodology