# K082467: Ensite Fusion Dynamic Registration Tool

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Sep 11, 2008 after 15 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.
29 later devices descend from it; 1 cites it directly.
0 of 30 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
- K160187: Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (2016), 28 descendants of its own
- K172396: EnSite Velocity Cardiac Mapping System v5.2 (2018), 27 descendants of its own
- K182644: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), 26 descendants of its own
- K183128: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), 25 descendants of its own
- K201181: EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System (2020), 18 descendants of its own

Source page: https://510kreport.com/device/K082467
Methodology: https://510kreport.com/methodology