# K992968: Carto EP Navigation System

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Sep 29, 1999 after 26 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 K954395 (1995). 1 ancestor in all.
36 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954395: Carto System, Biosense, Ltd. (1995) Summary page 1.

## Most influential descendants
- K993729: Modification to Carto EP Navigation System (1999), 34 descendants of its own
- K063277: Mapmate (2006), 33 descendants of its own
- 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

## Indications for use
The intended use of the CARTO mapping system is catheter-based cardiac mapping. The CARTO mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

Source page: https://510kreport.com/device/K992968
Methodology: https://510kreport.com/methodology