# K001437: Ensite 3000 System, Model EE3000

- Pathway: 510(k) (Special)
- Applicant: Endocardial Solutions, Inc.
- Decided: Jun 7, 2000 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
No predicates in its family tree.
60 later devices descend from it; 3 cite it directly.
0 of 61 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
- K012926: Modification to Ensite 3000 System, Model EE3000 (2001), 55 descendants of its own
- K030129: Modification to Ensite 3000 System, Model EE3000 (2003), 54 descendants of its own
- 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

Source page: https://510kreport.com/device/K001437
Methodology: https://510kreport.com/methodology