# K954395: Carto System

- Pathway: 510(k) (Traditional)
- Applicant: Biosense, Ltd.
- Decided: Dec 21, 1995 after 92 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
No predicates in its family tree.
57 later devices descend from it; 4 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992968: Carto EP Navigation System (1999), 36 descendants of its own
- 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

Source page: https://510kreport.com/device/K954395
Methodology: https://510kreport.com/methodology