# K151911: WorkMate Claris System, WorkMate Claris System Display Plus

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Oct 22, 2015 after 101 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: 7 generations back to K000248 (2000). 14 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132073: EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module, St Jude Medical (2013) Summary page 4.

## Most influential descendants
- K160218: AutoMark Module (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 WorkMate Claris™ System is indicated for use during clinical electrophysiology procedures. The WorkMate Claris™ System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors.

Source page: https://510kreport.com/device/K151911
Methodology: https://510kreport.com/methodology