# K000248: Carto EP Navigation System

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: May 5, 2000 after 99 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.
113 later devices descend from it; 2 cite it directly.
5 of 114 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
- K013083: Carto XP EP Navigation System (2001), 112 descendants of its own
- K020863: Carto XP and Qwikmap EP Navigation System (2003), 101 descendants of its own
- K042999: Carto XP EP Navigation System, Software Verison 8 (2005), 99 descendants of its own
- K070240: Carto XP EP Navigation System, Version 9 (2007), 58 descendants of its own
- K072202: Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01) (2007), 47 descendants of its own

Source page: https://510kreport.com/device/K000248
Methodology: https://510kreport.com/methodology