# K030129: Modification to Ensite 3000 System, Model EE3000

- Pathway: 510(k) (Traditional)
- Applicant: Endocardial Solutions, Inc.
- Decided: Apr 22, 2003 after 98 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: 2 generations back to K001437 (2000). 2 ancestors in all.
54 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012926: Modification to Ensite 3000 System, Model EE3000, Endocardial Solutions, Inc. (2001)

## Most influential descendants
- K042493: Ensite System, Model EE3000 (2004), 52 descendants of its own
- K060954: Modification to Ensite System, Model EE3000 (2006), 51 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
- K090017: Carto 3 EP Navigation System, V1.0 and Accessories (2009), 45 descendants of its own
- K093455: Carto 3 Version 1.05 EP Navigation System and Accessories (2009), 34 descendants of its own

## Indications for use
The EnSite 3000B System is indicated for patients for whom electrophysiology studies are indicated. When used with the EnSiteTMCatheter, the EnSite 3000B System is intended to be used in the right atrium of patients with complex arrhythmias that niay be difficult to identify using conventional mapping systems alone. OR When used with the EnSite NavXTMSurface Electrode Kit, the EnSite 3000B System is intended to display the position of conventional electrophysiology catheters in the heart.

Source page: https://510kreport.com/device/K030129
Methodology: https://510kreport.com/methodology