# K210392: WorkMate Claris System

- Pathway: 510(k) (Special)
- Applicant: Abbott
- Decided: Mar 11, 2021 after 29 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K000248 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- May 5, 2021 · Class II · Z-1854-2021: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
- May 5, 2021 · Class II · Z-1853-2021: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
- May 5, 2021 · Class II · Z-1855-2021: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

## Indications for use
The WorkMate ClarisTm System is indicated for the 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/K210392
Methodology: https://510kreport.com/methodology