# K063277: Mapmate

- Pathway: 510(k) (Special)
- Applicant: Ep Medsystems, Inc.
- Decided: Nov 30, 2006 after 30 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: 4 generations back to K000248 (2000). 10 ancestors in all.
33 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994011: EP Medsystems, EP-Workmate, Ep Medsystems, Inc. (2000) Summary page 1.
- K042681: Carto RMT EP Navigation System, Biosense Webster, Inc. (2005) Summary page 1.
- K042999: Carto XP EP Navigation System, Software Verison 8, Biosense Webster, Inc. (2005) Summary page 1.
- K020863: Carto XP and Qwikmap EP Navigation System, Biosense Webster, Inc. (2003) Summary page 1.
- K013083: Carto XP EP Navigation System, Biosense Webster, Inc. (2001) Summary page 1.
- K000248: Carto EP Navigation System, Biosense Webster, Inc. (2000) Summary page 1.
- K000190: Modification to Carto EP Navigation System, Biosense Webster, Inc. (2000) Summary page 1.
- K993729: Modification to Carto EP Navigation System, Biosense Webster, Inc. (1999) Summary page 1.
- K992968: Carto EP Navigation System, Biosense Webster, Inc. (1999) Summary page 1.
- K954395: Carto System, Biosense, Ltd. (1995) Summary page 2.

## Most influential descendants
- K092810: EP-Workmate System, Version 4.2 (2009), 32 descendants of its own
- K132073: EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module (2013), 31 descendants of its own
- K151911: WorkMate Claris System, WorkMate Claris System Display Plus (2015), 30 descendants of its own
- K160218: AutoMark Module (2016), 28 descendants of its own
- K172396: EnSite Velocity Cardiac Mapping System v5.2 (2018), 27 descendants of its own

## Indications for use
MapMate™ is indicated for use during clinical electrophysiology procedures.

Source page: https://510kreport.com/device/K063277
Methodology: https://510kreport.com/methodology