# K160218: AutoMark Module

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Dec 13, 2016 after 319 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: 8 generations back to K000248 (2000). 20 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141050: Ensite Velocity System, St Jude Medical (2014) Summary page 4.
- K151911: WorkMate Claris System, WorkMate Claris System Display Plus, St Jude Medical (2015) Summary page 4.

## Most influential descendants
- 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
- K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (2020), 17 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 EnSite™ Array Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping system alone. OR When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

Source page: https://510kreport.com/device/K160218
Methodology: https://510kreport.com/methodology