# K101667: Ensite Velocity System Referred to Ensite Velocity System with Positional Reference Tool (PRT)

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jul 2, 2010 after 18 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.
50 later devices descend from it; 2 cite it directly.
0 of 52 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
- K112688: Ensite Velocity System V.3.0 (2011), 48 descendants of its own
- K130594: Ensite Velocity System (2013), 46 descendants of its own
- K141050: Ensite Velocity System (2014), 33 descendants of its own
- K160210: EnSite Precision Cardiac Mapping System v2.0 (2016), 29 descendants of its own
- K130727: Ensite Velocity System (2013), 29 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 (EP) catheters in the heart.

Source page: https://510kreport.com/device/K101667
Methodology: https://510kreport.com/methodology